Source: https://www.massdevice.com/medical-device-recalls-november-2012/
Timestamp: 2017-02-22 17:26:48
Document Index: 136047513

Matched Legal Cases: ['art# 9200', 'art# 9100', 'art# 9015', 'art# 9300', 'art# 9120', 'art# 9102', 'art# 9106', 'art# 9105', 'art# 9300', 'art# 9500', 'art# 9200', 'art#9500']

Medical device recalls for November 2012 – MassDevice
Home » Medical device recalls for November 2012Medical device recalls for November 2012 December 3, 2012 By MassDevice staff Leave a Comment Class I recalls
Ventlab Corporation Nov-01-2012 Breath Tech; Safe Spot Infant Resuscitator – Breath Tech; Safe Spot Infant Resuscitator; BT2000 Series; Single use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028.The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 AirFlow Resuscitator; Adult Resuscitator – AirFlow Resuscitator; Adult Resuscitator; AF1000 Series; Single use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 Safe Spot Infant Resuscitator – Safe Spot Infant Resuscitator; Pro-1900 Series; Single Patient Use; The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 Ventlab Premium Small Child Resuscitator – Ventlab Premium Small Child Resuscitator; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 Ventlab Premium Small Adult Resuscitator – Ventlab Premium Small Adult Resuscitator; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028.The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 Ventlab Rescue Med Infant Resuscitator – Ventlab Rescue Med Infant Resuscitator; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028.The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 AirFlow; Infant Resuscitator – AirFlow; Infant Resuscitator; AF3000 Series; Single use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 AirFlow; Small Adult Resuscitator – AirFlow; Small Adult Resuscitator; AF5000 Series; Single use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 Stat-Check Resuscitator – Stat-Check Resuscitator; Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator; SC 9000 Series; Single use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028.The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 Adult Resuscitator; Pro-5000 Series – Adult Resuscitator; Pro-5000 Series; Single Patient Use; The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 Safe Spot Infant Resuscitator – Safe Spot Infant Resuscitator; SS3200 Series; Single Patient Use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Ventlab Corporation Nov-01-2012 V*Care Resuscitator Infant Resuscitator – V*Care Resuscitator Infant Resuscitator; VN 3000 Series; Single use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028.The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Mindray DS USA; Inc. d.b.a. Mindray North America Nov-16-2012 A3/A5 Anesthesia Delivery System – Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard; Mahwah; NJ 07430This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient’s ventilation. Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
Mindray DS USA; Inc. d.b.a. Mindray North America Nov-16-2012 A3/A5 Anesthesia Delivery System – Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard; Mahwah; NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient’s ventilation. Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
Ethicon; Inc. Nov-16-2012 ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin – ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville; NJ 08876 USA Ref 2993SURGIFLO Hemostatic Matrix; mixed with sterile saline or thrombin solution; is indicated for surgical procedures (except ophthalmic) for hemostasis; when control of capillary; venous and arteriolar bleeding by pressure; ligature; and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
Ethicon; Inc. Nov-16-2012 ETHICON SURGIFLO HEMOSTATIC MATRIX – ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON; Inc. Somerville; NJ 08876; USASURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix; mixed with sterile saline or thrombin solution; is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
Varian Medical Systems; Inc. Oncology Systems Nov-01-2012 ARIA Radiation Oncology Version 11 – ARIA Radiation Oncology; Version 11. Varian Medical Systems; Palo Alto; CA. The ARIA Radiation Oncology product is a treatment plan and image management application. An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect; when partial treatment is being continued.
Vital Images; Inc. Nov-01-2012 Software for Vitrea; Vitrea fX; and Vitrea Enterprise Suite (VES): – Software for Vitrea; Vitrea fX; and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2; 6.0; 6.1; and 6.2VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1; 5.2; 6.0; 6.1; and 6.2VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3; 6.0; 6.1; and 6.2.The software is a medical diagnostic system that allows the processing; review; analysis; communication; and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities; including CT; MR; DR; CR; XA; US; NM; PET; etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements; including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options; EKG Gate and Auto Gate; allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring. Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0; 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3; 6.0; 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.
Spacelabs Healthcare; Llc Nov-05-2012 Touchscreen Display Model 94267 – The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal — 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules. Potential failure of Spacelabs Healthcare Touchscreen Display; Model 94267 where the alarm lights failed to illuminate upon installation.
Sendx Medical Inc Nov-05-2012 ABL80 FLEX CO-OX analyzer – ABL80 FLEX CO-OX analyzer; model #393-841 (all software versions prior to 1.35).The ABL80 FLEX CO-OX is a portable; automated analyzer that measures pH; blood gases; electrolytes; glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists; nurses; physicians and therapists. It is intended for use in a laboratory environment; near patient or point of care setting The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
OrthoPediatrics Corp Nov-05-2012 Trochar Scalpel Instrument (Surgical Punch) – Trochar Scalpel Instrument (Surgical Punch)OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices; with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. A complaint received from sales representative that a replenishment instrument was too short. Upon investigation; it has been determined that the device was not manufactured to design specifications and will not function as intended.
Ormco/Sybronendo Nov-05-2012 Vector TAS Modular Driver – Vector TAS Modular Driver; a manual driver for Vector TAS dental screws. The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130?C. The correct sterilization temperature should be listed as 132?C and/or 270?F.
Philips Medical Systems (Cleveland); Inc. Nov-05-2012 Pinnacle3 Radiation Therapy Planning System – Pinnacle3 VCC P/N 4598 001 41341 REV A; Philips Medical Systems (Cleveland); Inc.; Fitchburg; WI.Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient’s radiation treatment. They are to be evaluated; modified and implemented by qualified medical personnel. Philips Medical Systems Cleveland); Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Nov-05-2012 SHARPOINT IQ Geometry Slit Knives – "***Sharpoint IQ Geometry Slit Knife Angled; Bevel Up***Surgical Specialties Corporation Reading; PA***REF 72-3240***"Ophthalmic surgery Potential for bent tips.
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Nov-05-2012 SHARPOINT IQ Geometry Slit Knives – "***Sharpoint IQ Geometry Slit Knife Angled; Bevel Up***Surgical Specialties Corporation Reading; PA***REF 72-2740***"Ophthalmic surgery Potential for bent tips.
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Nov-05-2012 SHARPOINT IQ Geometry Slit Knives – "***Sharpoint IQ Geometry Slit Knife Angled; Bevel Up***Surgical Specialties Corporation Reading; PA***REF 72-3040***"Ophthalmic surgery Potential for bent tips.
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Nov-05-2012 SHARPOINT IQ Geometry Slit Knives – "***Sharpoint IQ Geometry Slit Knife Angled; Bevel Up***Surgical Specialties Corporation Reading; PA***REF 72-2840***"Ophthalmic surgery Potential for bent tips.
Sechrist Industries Inc Nov-06-2012 Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module – Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ERThe Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Sechrist Industries Inc Nov-06-2012 Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module – Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ERThe Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Sysmex America; Inc. Nov-06-2012 Sysmex XE-2100C Automated Hematology System – Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation; Kobe; Japan; Sysmex America; One Nelson C. White Parkway; Mundelein; IL 60060; catalog #053-2311-4The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. There is a variation of reticulocyte counts between XE Series (XE-2100; XE-5000) and XT-Series (XT-2000i; XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Sysmex America; Inc. Nov-06-2012 Sysmex XE-5000 Automated Hematology System – Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation; Kobe; Japan; Sysmex America; One Nelson C. White Parkway; Mundelein; IL 60060; catalog #063-7591-7The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method; Sheath Row DC Detection Method; and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter; fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100; the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. There is a variation of reticulocyte counts between XE Series (XE-2100; XE-5000) and XT-Series (XT-2000i; XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Sysmex America; Inc. Nov-06-2012 Sysmex XE-2100 Automated Hematology System – Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation; Kobe; Japan; Sysmex America; One Nelson C. White Parkway; Mundelein; IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method; HydroDynamic Focusing (DC Detection); flow cytometry method (using a semiconductor laser); and SLS-hemoglobin method. There is a variation of reticulocyte counts between XE Series (XE-2100; XE-5000) and XT-Series (XT-2000i; XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Zimmer; Inc. Nov-06-2012 Metasul – Metasul¿ LDH¿ HeadRx Sterile Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Metasul – Metasul¿ Durom¿ Femoral componentSterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 MS-30¿ Stem – MS-30¿ Stem Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 MS-30 – MS-30¿ Distal centralizer; cemented; sterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 MS-30¿ Proximal positioner – MS-30¿ Proximal positioner Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Fitmore" Hip Stem – Fitmore" Hip Stem Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Wagner – Wagner cone Prosthesis; uncemented; sterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 CoCr Head; – CoCr Head; sterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder" Humeral stem – Anatomical Shoulder" Humeral stem Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder" Fracture Humeral stem – Anatomical Shoulder" Fracture Humeral stem Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder" Humeral Head – Anatomical Shoulder" Humeral Head Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 zimmer Anatomical Shoulder Glenoid S – zimmer Anatomical Shoulder Glenoid S; cemented; sterile; REF 01.04214.340 PE Keeled Glenoid S; cemented; sterile; REF 01.04214.345; Glenoid M; cemented; sterile; REF 01.04214.370; Glenoid L; cemented; sterile; REF 01.04214.400 PE Keeled Glenoid L; cemented; sterile; REF 01.04214.405 Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 zimmer Anatomical Shoulder – Anatomical Shoulder" Revision Humeral stem;7;9;12;14 andAnatomical Shoulder Fracture Humeral stem Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Zimmer Inverse/Reverse – Zimmer Inverse/Reverse Screw system; Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder" Inverse Humeral Cup – Anatomical Shoulder" Inverse Humeral Cup Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert – Anatomical Shoulder" Inverse/Reverse Humeral PE-InsertSterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder" Ball taper for humeral stem – Anatomical Shoulder" Ball taper for humeral stem Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder – Anatomical Shoulder" Fracture Humeral Head Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 CLS Stem – CLS Stem Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Original M.E. Mueller" Low Profile Cup – Original M.E. Mueller" Low Profile CupSterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Dynesys¿ Set screw M6 – Dynesys¿ Set screw M6 Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Dynesys – Dynesys¿ Universal spacer 6-45 Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Dynesys – Dynesys¿ L.I.S. Stabilizing cordRx; Sterile Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Dynesys¿ Revision + set screw – Dynesys¿ Revision + set screw Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Dynesys¿ HA Pedicle + set screw – Dynesys¿ HA Pedicle + set screw Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 DTO" Implant – DTO" Implant Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw – Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 NCB – NCB¿ cancellous screw Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 NCB¿ screw ¿ 4.0 self-tapping – NCB¿ screw ¿ 4.0 self-tapping Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 NCB¿-PT lateral proximal 3 hole tibial plate – NCB¿-PT lateral proximal 3 hole tibial plate Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 NCB¿-PH Plate – NCB¿-PH Plate Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Sirus – Sirus¿ intramedullary nail for tibia; cannulated ¿ Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Kopf – Kopf Adapter SSterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 MS-30 Shaft – MS-30 Shaft; Sterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Alloclassic – Alloclassic¿ SL-Offset Stemsterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Wagner SL Revision – Wagner SL Revision Stem; uncementedSterile Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Biolox – Biolox¿ Option Ceramic Femoral Head SystemRx; sterile Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Alloclassic – Biolox¿ delta Ceramic Femoral HeadRx only; sterile Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Alloclassic – Alloclassic SL Shaft Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Zimmer; Inc. Nov-06-2012 Anatomical Shoulder" Inverse/Reverse Glenoid – Anatomical Shoulder" Inverse/Reverse GlenoidSterile; Rx Zimmer Inc.; is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur; Switzerland; after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct; the info
Sunquest Information Systems; Inc. Nov-06-2012 Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface – Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface; v3.0.0_07222004 and later. The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
Sunquest Information Systems; Inc. Nov-06-2012 Sunquest Laboratory – Sunquest Laboratory; version 7.0not available Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event; a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.
Diagnostica Stago; Inc. Nov-06-2012 STA Satellite Automated Multi-Parameter Analyzer – STA Satellite Automated Multi-Parameter AnalyzerThis system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma; the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Following a single customer complaint that incorrect INR values were occasionally printed for PT tests; even though the primary units (seconds) were correct; the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite?.
Kimberly-Clark Corporation Nov-07-2012 ULTRA Fabric Reinforced surgical Gown X-Large Sterile – ULTRA Fabric Reinforced surgical Gown X-Large SterileThe product is a sterile; single use; surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms; body fluids; and particulate material. Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Kimberly-Clark Corporation Nov-07-2012 MicroCool Breathable Gown with Towels – MicroCool Breathable Gown with Towels; X-Larg; X-Long; SterileThe product is a sterile; single use; surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms; body fluids; and particulate material. Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
American Medical Systems; Inc. Nov-07-2012 "AdVance Male Sling System – AMS AdVance"" Male Sling System720088-01 AMS AdVance"" Male Sling System (US)720088-02 AMS AdVance"" Male Sling System (Intl)72404224 AMS Male TO Sling System (Intl).The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI)." American Medical Systems? (AMS) is issuing a voluntary recall on a number of lots of the AdVance? Male Sling System (AdVance).AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the
Medacta Usa Inc Nov-08-2012 Broach Handle; manual orthopedic surgical instrument – Quadra S Offset Broach HandleThe offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem. Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Stryker Howmedica Osteonics Corp. Nov-08-2012 Stryker Orthopaedics Hoffman LRF Telescopic Strut – Hoffman LRF Telescopic Strut ShortStrykerStryker Trauma AGCH-2545 SeizachDistributed in the USA by Howmedica Osteonics Corp.325 Corporate DriveMahwah; NJ 07430.The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful; the devices are manufactured from metal; plastic; and composite materials. No such fracture fixation device; subject to fatigue; can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system; therefore; will not be as strong; reliable or durable as a normal human bone. Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.
Alphatec Spine; Inc. Nov-08-2012 Zodiac Pedicle Screw System – TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55.Subsequent Product Codes: MNH; MNI.The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
Sorin Group USA; Inc. Nov-08-2012 Stockert S5/Sorin C5 System – S5 Mast Roller Pump 85; Item Number: 10-88-60The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Sorin Group USA; Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
Sorin Group USA; Inc. Nov-08-2012 Stockert S5/Sorin C5 System – S5 Double Roller Pump 85; Item Number: 10-85-00The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Sorin Group USA; Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
Sorin Group USA; Inc. Nov-08-2012 Stockert S5/Sorin C5 System – S5 Single Roller Pump 150; Item Number: 10-80-00The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Sorin Group USA; Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of theSorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determi
Sorin Group USA; Inc. Nov-08-2012 Stockert S5/Sorin C5 System – S5 Mast Roller Pump 150; Item Number: 10-88-00The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Sorin Group USA; Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
Sorin Group USA; Inc. Nov-08-2012 Stockert S5/Sorin C5 System – Sorin C5 Perfusion System; Item number 58-00-00The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Sorin Group USA; Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
Shimadzu Medical Systems Nov-08-2012 System; x-ray; mobile – 0.4/0.7JG326D-265AX/AT Product Usage:The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device; Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards; 21CFR 1020.30 (m) Beam quality –(1) Half-value layer (HVL); which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Shimadzu Medical Systems Nov-08-2012 System; x-ray; mobile – 0.7/1.2JG326D-265 Product Usage:The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device; Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards; 21CFR 1020.30 (m) Beam quality –(1) Half-value layer (HVL); which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Shimadzu Medical Systems Nov-08-2012 MobileArt Evolution; MobileDaRt Evolution – 0.7/1.3U163CS-36In combination with below systemsMobileArt Evolution; MobileDaRt EvolutionProduct Usage:The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device; Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards; 21CFR 1020.30 (m) Beam quality –(1) Half-value layer (HVL); which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Shimadzu Medical Systems Nov-08-2012 MUX-100H. Mobile x-ray system. – 0.7U163CS-36In combination with below systemsMUX-100H; MUX-100D; MobileArt EvolutionBrand Name: MUX-100H. Classification Name: Mobile x-ray system.Device Model#MUX-100H.Product Usage:The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device; Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards; 21CFR 1020.30 (m) Beam quality –(1) Half-value layer (HVL); which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Shimadzu Medical Systems Nov-08-2012 R-20J; Diagnostic X-ray Beam Limiting Device – R-20J ; Diagnostic X-Ray Beam-Limiting Device.In combination with any of below X-Ray tubes: 06/1.2P364DK-85; 0.6/1.2P324DK-125;06/1.2P324DK-85; 0.6/1.2P38DE-85.Product Usage:The device is the beam-limiting device for X-ray Radiography. Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device; Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards; 21CFR 1020.30 (m) Beam quality –(1) Half-value layer (HVL); which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Shimadzu Medical Systems Nov-08-2012 R-30H; Diagnostic X-ray Beam Limiting Device – R-30H ; Diagnostic X-Ray Beam-Limiting Device.In combination with any of below X-ray tubes0.6/1.2P364DK-85; 0.6/1.2P324DK-125;0.6/1.2P324DK-85; 0.6/1.2P38DE-85Device Model # R-30H.Subsequent Product Code: IZXProduct Usage:The device is the beam-limiting device for X-ray Radiography. Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device; Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards; 21CFR 1020.30 (m) Beam quality –(1) Half-value layer (HVL); which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Kerr Corporation Nov-08-2012 "AlgiNot – The brand name of the device is AlgiNot; a dental impression material.Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017AlgiNot is a Class II Medical Device. The device listing number this product is0136496 and the establishment registration number for Kerr Corporation is 1815757.Intended as an alternative to traditional alginate materials." The firm recalled the product because it may cure harder than expected within theshelf life; which could result in a material that may be more difficult to remove. Use of this product onpatients with loose teeth may result in possible tooth fracture or tooth extraction.
Primus Medical LLC Nov-08-2012 Prime Bed TL500 Bed Frame – AC Powered adjustable hospital bed; Prime Bed TL500; Distributed by: Primus Medical LLC; 8401 Southern Blvd; Boardman; OH 44512.Usage: Hospital Bed. The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.
Progressive Medical Inc Nov-09-2012 Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm c 40cm) – Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm); Reorder Number: PMILK40; Product Sterile in Unopened/Undamaged pouch; Cotton Tip – X-Ray Detectable; 1 Pc/Pouch; 10 Pouches/Box; 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical; Inc.; St. Louis; MO; Made in China.The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU; the indications for use are for gynecological laparoscopy; laparoscopic cholecystectomy; and other laparoscopic procedures. Some of the sterile packages had broken seals.
Terumo Cardiovascular Systems Corporation Nov-13-2012 HX2 Temp Manage SYS 120V – HX2 Temp Manage SYS 120VThe Terumo HX2 Temperature Management System is a selfcontained; dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. Based on a retrospective review of quality data; AC Control boards used in the manufacture of theHX2 Temperature Management System were identified as being manufactured using the incorrectflux material. Use of the incorrect flux may contribute to premature board failure. A search ofTCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurredduring set up
Stryker Howmedica Osteonics Corp. Nov-13-2012 Stryker Orthopaedics – Special Orthopaedic Solution Peri-Acetabular ProsthesisV40 Femoral Extension ComponentProduct Usage:The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection. Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
Terumo Cardiovascular Systems Corporation Nov-13-2012 Tested AC Control BD – Tested AC Control BD; 120V; X2The Terumo HX2 Temperature Management System is a selfcontained; dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. Based on a retrospective review of quality data; AC Control boards used in the manufacture of theHX2 Temperature Management System were identified as being manufactured using the incorrectflux material. Use of the incorrect flux may contribute to premature board failure. A search ofTCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurredduring set up
Synthes USA HQ; Inc. Nov-13-2012 Synthes External Fixation System Tube to Tube Clamp; Part Number 390.007 – Synthes External Fixation System Tube to Tube Clamp; Part Number 390.007.Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically; the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures; or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems – failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening. The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.
Terumo Cardiovascular Systems Corporation Nov-13-2012 Sams Modular Perfusion System 8000 – Perfusion System 8000; base 5 pump; 100V safety monitor includedThe Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns ModularPerfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions; inability to measure pressure and inaccurate and/or false pressurealarms.If the malfunction of the arterial or cardio
Terumo Cardiovascular Systems Corporation Nov-13-2012 Sams Modular Perfusion System 8000 – Perfusion System 8000; base 5 pump; 220V/240V safety monitor includedThe Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns ModularPerfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions; inability to measure pressure and inaccurate and/or false pressurealarms.If the malfunction of the arterial or cardio
Terumo Cardiovascular Systems Corporation Nov-13-2012 Sams Modular Perfusion System 8000 – Perfusion System 8000; base 4 pump; 220V/240V safety monitor includedThe Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns ModularPerfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions; inability to measure pressure and inaccurate and/or false pressurealarms.If the malfunction of the arterial or cardio
Terumo Cardiovascular Systems Corporation Nov-13-2012 Sams Modular Perfusion System 8000 – Perfusion System 8000; base 5 pump; 115V safety monitor includedThe Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns ModularPerfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions; inability to measure pressure and inaccurate and/or false pressurealarms.If the malfunction of the arterial or cardio
Terumo Cardiovascular Systems Corporation Nov-13-2012 Sams Modular Perfusion System 8000 – Perfusion System 8000; base 4 pump; 115V safety monitor includedThe Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns ModularPerfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions; inability to measure pressure and inaccurate and/or false pressurealarms.If the malfunction of the arterial or cardio
Terumo Cardiovascular Systems Corporation Nov-13-2012 Sams Modular Perfusion System 8000 – Perfusion System 8000; base 4 pump; 100V safety monitor includedThe Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns ModularPerfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions; inability to measure pressure and inaccurate and/or false pressurealarms.If the malfunction of the arterial or cardio
Trivascular; Inc Nov-13-2012 TriVascular Fill Polymer Kit – TriVascular brand Fill Polymer Kit; Endovascular Graft; Aneurysm Treatment System; European Model Number: TVFP14-B; (in European distributor inventory only); PRODUCT Usage:The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair; including: (1) Adequate iliac/femoral access compatible with vascular access techniques; devices; and/or accessories; (2) Non-aneurysmal proximal aortic neck: – with a length of at least 7 mm proximal to the aneurysm; – with an inner wall diameter of no less than 16 mm and no greater than 30 mm; and – with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm; (3) Non-aneurysmal distal iliac landing zone: – with a length of at least 10 mm; – with an inner wall diameter of no less than 8 mm and no greater than 20 mm Selected lots of the Fill Polymer Kit (European Model Number: TVFP14-B) in European distributor inventory only that potentially contain leaking stopcocks due topossible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in
Dako North America Inc. Nov-13-2012 PT100/PT Link Waterbath – PT Link Waterbath; Model#PT100.Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically; if the heater pad under the reagent tank becomes wet; it may present an electrical shock hazard when the lid is open.
MOOG Medical Devices Group Nov-15-2012 Infinity Pump – EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications.The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications. MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
Zimmer; Inc. Nov-15-2012 ATS 3000 Automatic Tourniquet System – ATS 3000 Automatic Tourniquet Systemw/HOSES AND LOP SENSORIntended to be used by qualified medical professionals to temporarily occlude blood flow in a patient’s extremities during surgical procedures on those extremities. Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm; lock into a non-operational mode; and the display screen will go blank. Based on investigation; this problem appears to be due to a counterfeit chip on the
Gulf South Medical Supply Inc Nov-15-2012 Vinyl Powder-Free Exam Gloves – Select Medical Products Vinyl Powder-Free Exam Gloves; Medium Model # 6370 and Large Model # 6371; 100 per box; 10 boxes per case.Usage: Patient Examination. Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
Biomet 3i; LLC Nov-16-2012 Dental implant – Product is Full OSSEOTITE 2 Tapered Certain Implant; Model Number XIFNT413; and size 4 x 13 mm. The product is sterile.Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant’s internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
Biomet 3i; LLC Nov-16-2012 Dental implant – Product is Full OSSEOTITE Parallel Walled Certain Implant; Model Number IFOA411. The product is sterile.Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant’s internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
Vital Signs Devices; a GE Healthcare Company Nov-16-2012 Corometrics Qwik Connect Plus Spiral Electrode – Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 50mm Disc; 3.0%; Part# 9200-30.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 32mm Disc; 3.0%; Part# 9100-30.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 7.5mm x 19mm Cone; 3.0%; Part# 9015-30; 9003-30.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 85mm x 85mm Pledget; 1.5%; Part# 9300-15.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 32mm Disc; 1.5%; Part# 9120-15; 9100-15.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 4×4 Pledget; 3.0%; Part# 9102-00.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 2×2 Pledget; 3.0%; Part# 9106-00. For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 2×2 Pledget; 1.5%; Part# 9105-00.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 85mm x 85mm Pledget; 3.0%; Part# 9300-30. For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 115mm x 115mm Pledget; 3.0%; Part# 9500-30.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic Sponge – Superstat Modified Collagen Hemostatic Sponge; 50mm Disc; 1.5%; Part# 9200-15.For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Superstat Corp Nov-16-2012 Superstat Modified Collagen Hemostatic – Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget; 1.5%; Part#9500-15. For use when hemostasis is desired along suture lines; in diffusely bleeding sites; in incisions; dissections; and around arterial or venous anastomoses. Indicated in oozing bleeding; either capillary or venous; in almost all types of incisions or wounds; and as an adjunct to conventional closure techniques The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; USB Instrument & Update – bioMerieux Kit; USB Instrument & Update; 3D B.40 USB-ML03; Clinical instrument software; Danish; Greek; Polish; Portuguese; catalog number 412559Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux BacT/ALERT Combo Module – bioMerieux BacT/ALERT Combo Module; catalog number; 200290; Clinical instrumentThe product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 USB-ML05; Clinical instrument software; Lithuanian; Latvian; Russian; Slovak; catalog number 412621Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 USB-ML06; Clinical instrument software; Japanese; Korean; Norwegian; Brazilian; Portuguese; Turkish; catalog number 412622Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux BacT/ALERT Control Module – bioMerieux BacT/ALERT Control Module; catalog number 210148; Industrial instrumentThe product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux BacT/ALERT Combo Module – bioMerieux BacT/ALERT Combo Module; catalog number 200291; Industrial instrumentThe product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux BacT/ALERT Combo Module – bioMerieux BacT/ALERT Combo Module; catalog number 247014; Industrial instrumentThe product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D IND ZIP-ML 01; Industry instrument software update; English; Spanish; Italian; catalog number 412005Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D IND USB-ML 02; Industry instrument software update; English; Spanish; Italian; catalog number 412006Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; B.40 Dualt-ML; Industry instrument software update; English; Spanish; Italian; German; French; Japanese; Brazilian; Portuguese; catalog number 412950Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; B.40; 3D IND USB-ML01; Industry instrument software update; English; Spanish; Italian; catalog number 412002Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; B.40; 3D IND USB-ML02; Industry instrument software update; German; French; catalog number 412003Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; B.40; 3D I USB-ML01; Industry instrument software update; English; Spanish; Italian; catalog number 413481Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update; B.40; 3D I USB-ML02 – bioMerieux Kit; Instrument & Update; B.40; 3D I USB-ML02; Industry instrument software update; German; French; catalog number 413482Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update; B.40; 3D I ZIP-ML01 – bioMerieux Kit; Instrument & Update; B.40; 3D I ZIP-ML01; Industry instrument software update; English; Spanish; Italian; catalog number 413483Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update; B.40; 3D I ZIP-ML02 – bioMerieux Kit; Instrument & Update; B.40; 3D I ZIP-ML02; Industry instrument software update; English; Spanish; Italian; catalog number 413484Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 USB-ML04; Clinical instrument software; Czech; Estonian; Hungarian; Romanian; catalog number 412620Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux BacT/ALERT 3D 60 – bioMerieux BacT/ALERT 3D 60; catalog number; 248009; Clinical instrumentThe product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 ZIP-ML01; Clinical instrument software; English; Spanish; Italian; catalog number 411814Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 ZIP-ML 02; Clinical instrument software; English; Spanish; Italian; catalog number 411815Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux BacT/ALERT Control Module – bioMerieux BacT/ALERT Control Module; catalog number 210147; Clinical instrumentThe product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; USB HDW; BTA3D CONTROL-B-B.40 – bioMerieux Kit; USB HDW; BTA3D CONTROL-B-B.40; Clinical instrument software; USB update and mounting hardware-English; catalog number 411958Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; USB HDW; BTA3D COMBO-B-B.40 – bioMerieux Kit; USB HDW; BTA3D COMBO-B-B.40; Clinical instrument software; USB update and mounting hardware-English; catalog number 411957Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; USB HDW – bioMerieux Kit; USB HDW; BTA3D60-B-B.40; Clinical instrument software; USB update and mounting hardware-English; catalog number 411956Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 USB-ML02; Clinical instrument software; German; French; Swedish; catalog number 411925Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 USB-ML01; Clinical instrument software; English; Spanish; Italian; catalog number 411818Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 ZIP-ML06; Clinical instrument software; Japanese; Korean; Norwegian; Brazilian; Portuguese; Turkish; catalog number 412626Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 ZIP-ML05; Clinical instrument software; Lithuanian; Latvian; Russian; Slovak; catalog number 412625Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 ZIP-ML04; Clinical instrument software; Czech; Estonian; Hungarian; Romanian; catalog number 412624Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 ZIP-ML03; Clinical instrument software; Danish; Greek; Polish; Portuguese; catalog number 412623Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Biomerieux Inc Nov-16-2012 bioMerieux Kit; Instrument & Update – bioMerieux Kit; Instrument & Update; 3D B.40 BTA3D-ZH01; Clinical instrument software; Chinese; catalog number 411816Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection; which can be due to a variety of sources including lung; abdomen; urinary tract; endovascular; and skin. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
GE Healthcare; LLC Nov-16-2012 Mobile X – Ray Series – GE Healthcare Optima XR 200amx with digital upgradeMobile general purpose radiographic imaging of the human head and body. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product; Brivo XR285amx; Optima XR200amx; Optima XR22Oamx and Optima XR200amx with Digital Upgrade; related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
GE Healthcare; LLC Nov-16-2012 Mobile X – Ray Series – GE Healthcare Optima XR 220amxMobile general purpose radiographic imaging of the human head and body. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product; Brivo XR285amx; Optima XR200amx; Optima XR22Oamx and Optima XR200amx with Digital Upgrade; related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
GE Healthcare; LLC Nov-16-2012 Mobile X – Ray Series – GE Healthcare Brivo XR 285Mobile general purpose radiographic imaging of the human head and body. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product; Brivo XR285amx; Optima XR200amx; Optima XR22Oamx and Optima XR200amx with Digital Upgrade; related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
GE Healthcare; LLC Nov-16-2012 Mobile X – Ray Series – GE Healthcare Optima 200amxMobile general purpose radiographic imaging of the human head and body. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product; Brivo XR285amx; Optima XR200amx; Optima XR22Oamx and Optima XR200amx with Digital Upgrade; related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Extremity Medical LLC Nov-18-2012 IO FIX IntraOsseous Fixation – IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079.The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses; osteotomies; intra- and extrarticular fractures and nonunions of the small bones and joints of the foot; ankle; hand and wrist. Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Zimmer; Inc. Nov-19-2012 VerSys Hip System Provisional Femoral Head 12/14 Neck Taper – Product 100789502202 VerSys Femoral Head Provisional 22mm +000789502203 VerSys Femoral Head Provisional 22mm +3.500789502220 VerSys Femoral Head Provisional 22mm -200789502230 VerSys Femoral Head Provisional 22mm +312/14 Neck TaperThe provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 VerSys Hip System Provisional Femoral Head 12/14 Neck Taper – 00789502601 VerSys Femoral Head Provisional 26mm -3.500789502602 VerSys Femoral Head Provisional 26mm +000789502603 VerSys Femoral Head Provisional 26mm +3.500789502604 VerSys Femoral Head Provisional 26mm +700789502605 VerSys Femoral Head Provisional 26mm +10.512/14 Neck TaperThe provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 VerSys Hip System Provisional Femoral Head 12/14 Neck Taper – . 00789502801 VerSys Femoral Head Provisional 28mm -3.500789502802 VerSys Femoral Head Provisional 28mm +000789502803 VerSys Femoral Head Provisional 28mm +3.500789502804 VerSys Femoral Head Provisional 28mm +700789502805 VerSys Femoral Head Provisional 28mm +10.512/14 Neck TaperThe provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 VerSys Hip System Provisional Femoral Head 12/14 Neck Taper – 00789503201 VerSys Femoral Head Provisional 32mm -3.500789503202 VerSys Femoral Head Provisional 32mm +000789503203 VerSys Femoral Head Provisional 32mm +3.500789503204 VerSys Femoral Head Provisional 32mm +700789503205 VerSys Femoral Head Provisional 32mm +10.512/14 Neck TaperThe provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 VerSys Hip System Provisional Femoral Head 12/14 Neck Taper – . 00789503601 VerSys Femoral Head Provisional 36mm -3.500789503602 VerSys Femoral Head Provisional 36mm +000789503603 VerSys Femoral Head Provisional 36mm +3.500789503604 VerSys Femoral Head Provisional 36mm +700789503605 VerSys Femoral Head Provisional 36mm +10.512/14 Neck TaperThe provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 VerSys Hip System Provisional Femoral Head 12/14 Neck Taper – 00789504001 VerSys Femoral Head Provisional 40mm -3.500789504002 VerSys Femoral Head Provisional 40mm +000789504003 VerSys Femoral Head Provisional 40mm +3.500789504004 VerSys Femoral Head Provisional 40mm +700789504005 VerSys Femoral Head Provisional 40mm +10.5The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 MIS Slotted Femoral Head Provisional – 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X2200780302202 MIS 12/14 Slotted Femoral Head Provisional +0X2200780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 MIS Slotted Femoral Head Provisional – 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X2600780302602 MIS 12/14 Slotted Femoral Head Provisional +0X2600780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X2600780302604 MIS 12/14 Slotted Femoral Head Provisional +7X2600780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type
Zimmer; Inc. Nov-19-2012 MIS Slotted Femoral Head Provisional – 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X2800780302802 MIS 12/14 Slotted Femoral Head Provisional +0X2800780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X2800780302804 MIS 12/14 Slotted Femoral Head Provisional +7X2800780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X2800780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type
Zimmer; Inc. Nov-19-2012 MIS Slotted Femoral Head Provisional – 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X3200780303202 MIS 12/14 Slotted Femoral Head Provisional +0X3200780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X3200780303204 MIS 12/14 Slotted Femoral Head Provisional +7X3200780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X3200780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Zimmer; Inc. Nov-19-2012 MIS Slotted Femoral Head Provisional – 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X3600780303602 MIS 12/14 Slotted Femoral Head Provisional +0X3600780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X3600780303604 MIS 12/14 Slotted Femoral Head Provisional +7X3600780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type
Zimmer; Inc. Nov-19-2012 MIS Slotted Femoral Head Provisional – 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X3600780304002 MIS 12/14 Slotted Femoral Head Provisional +0X3600780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X3600780304004 MIS 12/14 Slotted Femoral Head Provisional +7X3600780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this typ
Stryker Spine Nov-19-2012 Stryker XIA 3 TORQUE WRENCH – Stryker XIA 3 TORQUE WRENCHREF 48237028Manufactured by:Stryker pine SASZ.I MARTICOT-33610-CESTAS-FRANCE+33 (0)5.57.97.06.30http://www.stryker.comDistributed in the USA by:Stryker Spine;2 Pearl Ct. AllendaleNJ 07401-1677 USA+1-201-780-8000The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws; Hooks; Monoaxial Screws; Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached. Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Stryker Spine Nov-19-2012 Stryker MANTIS TORQUE WRENCH – Stryker MANTIS TORQUE WRENCHREF 48287028Manufactured by:Stryker pine SASZ.I MARTICOT-33610-CESTAS-FRANCE+33 (0)5.57.97.06.30http://www.stryker.comDistributed in the USA by:Stryker Spine;2 Pearl Ct. AllendaleNJ 07401-1677 USA+1-201-780-8000The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws; Hooks; Monoaxial Screws; Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached. Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Stryker Spine Nov-19-2012 SPECIALTY AUDIBLE TORQUE WRENCH – SPECIALTY AUDIBLE TORQUE WRENCH; XIAIS2217XLPMFG BY: STRYKER SPINE2 PEARL COURTALLENDALE NJ 07401-1677The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws; Hooks; Monoaxial Screws; Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached. Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Stryker Howmedica Osteonics Corp. Nov-19-2012 Torx 6.5mm Cancellous Bone Screw – Stryker Orthopaedics Torx 6.5mmCancellous Bone ScrewRef 2030-6535-1The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation. Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely; packaging associated with a 25mm screw may contain a 35mm screw.
Stryker Howmedica Osteonics Corp. Nov-19-2012 Torx 6.5mm Cancellous Bone Screw – Stryker Orthopaedics Torx 6.5mmCancellous Bone ScrewRef 2030-6525-1The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation. Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely; packaging associated with a 25mm screw may contain a 35mm screw.
Mako Surgical Corporation Nov-19-2012 The RIO (TGS 2.); – The RIO (TGS 2.); Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures; in which the use of stereotactic surgery may be appropriate; and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA). MAKO Surgical Group recalled their RIO System software; version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system’s software. Loss of tactile feedback constraining the cutting burr has been reported.
Linvatec Corp. dba ConMed Linvatec Nov-19-2012 Surgical Bit – "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO; FL 33773-4908 USA***LOT***2009-02***".This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. Linvatec Corporation dba ConMed Linvatec in Largo; FL is recalling the S8580; 8.0MM SENTINEL Cannulated Drill Bit; lot numbers 322225 and 322226; and the S8585; 8.5MM SENTINEL Cannulated Drill Bit; lot number 322287. Recall was initiated due to the incorrect labeling on package.
Linvatec Corp. dba ConMed Linvatec Nov-19-2012 Surgical Bit – "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO; FL 33773-4908 USA***LOT***2012-03***".This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. Linvatec Corporation dba ConMed Linvatec in Largo; FL is recalling the S8580; 8.0MM SENTINEL Cannulated Drill Bit; lot numbers 322225 and 322226; and the S8585; 8.5MM SENTINEL Cannulated Drill Bit; lot number 322287. Recall was initiated due to the incorrect labeling on package.
Beckman Coulter Inc. Nov-19-2012 UniCel Dxl 800 Access Immunoassay System – UniCel Dxl 800 Access Immunoassay System; Part Numbers: 973100; A71456; and A71457.The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Beckman Coulter Inc. Nov-19-2012 UniCel Dxl 600 Access Immunoassay System – UniCel Dxl 600 Access Immunoassay System; Part Numbers: A30260; A71460; and A71461.The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Beckman Coulter Inc. Nov-19-2012 UniCel DxC 880i; 860i; 680i; and 660i Integrated Systems – UniCel DxC 880i; 860i; 680i; and 660i Integrated Systems; Part Numbers: A64871; A64903; A64935; A59102.The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer. The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 55mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 30mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 35mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 40mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 45mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 50mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 55mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – Screw Tulip ; 5.5mm RodSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 4.5mm x 35mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 4.5mm x 40mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 40mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 45mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 50mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 40mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 45mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 50mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 40mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 45mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 7.5mm x 50mm Noncannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 50mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 45mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 40mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 35mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 6.5mm x 30mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 55mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 50mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 45mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 40mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 35mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – Screw Tulip ; 6.25mm RodSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
NuVasive Inc Nov-19-2012 SpheRx¿ Posted Pedicle Screw System – 5.5mm x 30mm Cannulated Screw ShankSubsequent Codes: KWP; KWQ; MNH; MNI The tulip portion of the screw assembly can disengage from the shank after implantation.
Siemens Healthcare Diagnostics; Inc. Nov-20-2012 Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Reagent Cartridge (K4071) – Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071)The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system. Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations; QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.
Gyrus Acmi; Incorporated Nov-20-2012 PARPARELLA-TYPE VENT TUBE; 1.02 MM – PARPARELLA-TYPE VENT TUBE; 1.02 MM; SILICONE; REF 240044; QTY 6; Rx Only; STERILE EO; GYRUS ACMI INC.;Tympanostomy tube One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Kerr Corporation Nov-20-2012 Surgical Headlight – Freedom Cordless LED Light System. Freedom System; Standard Length; Part Number 910863-1; Serial Numbers 77001000-77003470 and Freedom System; Long Length; Part Number 910863-2; Serial Numbers 77001000-77003470.Freedom Cordless LED Light System is a Class I Medical Device. The devicelisting number this product is E115952.The intended use of this device is to illuminate oral structures and operating areas. The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in thecontrol board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however; no skin damage will occur.
Vital Signs Colorado Inc. Nov-20-2012 VITAL-TEMP General Purpose Probe – Vital Signs Disposable General Purpose 9 French Temperature ProbeFor monitoring of core temperature There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Spacelabs Healthcare; Llc Nov-20-2012 Qube Compact Monitor Model 91390 – qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches – 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390); functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules; Flexports interfaces; and other SDLC based products in the form of waveform and numeric displays; trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module; consist of ECU; respiration; invasive and noninvasive blood pressure; Sp02; temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high; medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal; the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays; network devices; serial devices; user input devices; audio systems; and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a hospital environment. Spacelabs Healthcare has learned through severalreports that the input circuit may fail and the monitorwill go on battery mode. The monitor will functionnormally until the batteries become depleted and thenthe monitor will shut down. In addition the monitor mayfail to turn on due to an internal short.
Zimmer; Inc. Nov-20-2012 Multipolar – Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22Product Usage:The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated; as noted in surgical technique 97-5003-003-00 Zimmer Inc. is initiating a removal of the Multipolar? Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
Kerr Corporation Nov-20-2012 BioPlant – BioPlant; a dental bone grafting material. BioPlanthas been assigned the product code LYC (Bone Grafting Material; Synthetic) by theFDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254.BioPlant is a synthetic; multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery; ridge preservation; ridge augmentation; augmentations in the maxillary sinus; repair of periodontal defects and bone voids associated with dental implant placement. The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
KCI USA; Inc. Nov-20-2012 RotoRest Delta Kinetic Therapy System – RotoRest Delta Kinetic Therapy SystemINDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility; Thoracic or lumbar fracture; Cervical traction; Skeletal traction The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances; the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Zimmer; Inc. Nov-20-2012 Trilogy – Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty. Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct; matching the product inside the carton.
Carl Zeiss Meditec; Inc. Nov-20-2012 INTRABEAM Balloon Applicator Set – INTRABEAM Balloon Applicator Set;3.0 cm;Carl Zeiss Meditec AG; Oberkochen; GermanyINTRABEAM System is intended for radiation therapy treatments A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Carl Zeiss Meditec; Inc. Nov-20-2012 INTRABEAM Balloon Applicator Set; – INTRABEAM Balloon Applicator Set;4.0 cm;Carl Zeiss Meditec AG; Oberkochen; GermanyINTRABEAM System is intended for radiation therapy treatments. A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Carl Zeiss Meditec; Inc. Nov-20-2012 INTRABEAM Balloon Applicator Set – INTRABEAM Balloon Applicator Set;3.5 cm;Carl Zeiss Meditec AG; Oberkochen; GermanyINTRABEAM System is intended for radiation therapy treatments. A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
SpineFrontier; Inc. Nov-21-2012 S-Lift Implant Guides – S-Lift Implant Guides (also known as S-LIF)Compressor Part Number: 11-50223Product Usage:Surgical Guides allow a surgeon to place implants into tight spaces; such as a vertebral disc space; without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides; they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae. When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops; there is a known risk of moving the Implant Guides; and possibly the implant; too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
Kerr Corporation Nov-21-2012 Laser Loupes – The brand name of the device is Laser Loupes; a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices.Laser Loupes areavailable with four (4) different filters of different colors. Each colored filter isassociated with specific laser frequency ranges. The device listing number for this product is E160359.The intended use of this device is to magnify the operatory field and provide laser eye protection. The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protectsagainst may wipe off. The loupes work according to specification; but the marking may not permanently adhere tothe device.
Biomet; Inc. Nov-21-2012 Ranawat/Burnstein Acetabular Shell – Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic; full-hemisphere; acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation; joint or bone loss; soft tissue laxity; neuromuscular disease; or intra-operative instability and for whom all other options to constrained acetabular components have been considered The color code on label conflicts with the liner size (liner size 24 should be green; not yellow)
Zimmer; Inc. Nov-21-2012 Zimmer Trilogy – The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis; avascular necrosis; protrusio acetabuli; traumatic arthritis; slipped capital epiphysis; fused Hip; fracture of the pelvis; and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security; particularly in those cases where acetabular bone stock is deficient. Zimmer Trilogy? Acetabular System Shell with Cluster Holes; Porous;56 MM O.D.; sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
Innovative Magnetic Resonance Imaging Systems Inc. Nov-21-2012 IMRIS ORT100 and ORT 200 – IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00); are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems. IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed; the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
Captiva Spine; Inc Nov-21-2012 CapLOX II Pedicle Screw System – CapLOX II Final Torque Driver; Indicator is a Pedicle screw spinal system.The CapLOX II Spinal System is a posterior; non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic; lumbar; and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; pseudoarthrosis and failed previous fusion. Captiva Spine recalled their CapLOX II Final Torque Driver; Indicator due to the device prematurely breaking
SpineFrontier; Inc. Nov-21-2012 Spine Frontier Inspan Compressor – Spine Frontier Inspan compressorsPart Number: 11-60004.Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone; resulting in fixation of the implant. Inspan Compressors may break at weld causing a loss of compression
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD Flexible ClearSeal SINGLE USE; King Systems ETO Sterilie; 10 devices/case"Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg "Product Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD Standard ClearSeal SINGLE USE; King Systems ETO Sterilie; 20 devices/caseSize 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD Standard ClearSeal SINGLE USE; King Systems ETO Sterilie; 10 devices/caseSize 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD Standard ClearSeal SINGLE USE; King Systems ETO Sterilie; 10 devices/caseSize 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kgProduct Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD Standard ClearSeal SINGLE USE; King Systems ETO Sterilie10 devices/caseSize 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD SILI CONE SINGLE USE; King Systems; 10 devices/case; ETO SterileSize 5 / Adult Silicone King LAD¿ Patient Size: >70kgProduct Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD SILI CONE SINGLE USE; King Systems; 10 devices/case; ETO SterileSize 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD SILI CONE SINGLE USE; King Systems; 10 devices/case; ETO SterileSize 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD SILI CONE SINGLE USE; King Systemsdevices/case; ETO Sterile.Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
King Systems Corp. Nov-21-2012 KING LAD SILI CONE – KING LAD Flexible ClearSeal SINGLE USE; King Systems ETO Sterilie; 10 devices/case"Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg "Product Usage:Laryngeal airway The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
Stryker Orthobiologics; Inc. Nov-22-2012 Styker Orthobiologics Vita Plasma Separator; a component of Vitagel Surgical Hemostat – Styker Orthobiologics Vita Plasma Separator; a component of Vitagel Surgical Hemostat.Sterile; single use device designed to prepare plasma from the patient’s blood using a tabletop centrifuge. When preparing plasma using VitaPrep; it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step; this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
Sentec AG Nov-22-2012 V-Sign Membrane Changer – SenTec V-Sign Membrane Changer Insert (VS-MCI); 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only.The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension; oxygen saturation; and pulse rate are required for adult and pediatric patients. A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
Sentec AG Nov-22-2012 V-Sign Membrane Changer – SenTec V-Sign Membrane Changer (VS-MC); 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only.The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension; oxygen saturation; and pulse rate are required for adult and pediatric patients. A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
OrthoPediatrics Corp Nov-22-2012 4.5mm PLEO Osteotomy Guide. – 4.5mm PLEO Osteotomy Guide.OrthoPediatrics Corp. markets a pediatric; extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I; 4.5mm PLEO Osteotomy Guide Instrument; common name: Guide; Surgical; Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates; left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents; above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique; nor required to perform the procedure. Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation; it has been determined that the device was not manufactured to design specifications and will not function as intended.
Biomerieux Inc Nov-22-2012 Sodium Chloride (NaCl) Injection – 0.9% Sodium Chloride Injections; USP; 1000ml; VWR/BaxterProduct Usage:The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections; and the system is designed to use 0.45%-0.50% sodium chloride concentration only. The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.
Extremity Medical LLC Nov-26-2012 IO FiX X-Post Reamer – IO FiX X-Post Reamer; Extremity Medical; www.extremitymedical.com; Customer Service: 888.499.0079The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures. Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Cooper Surgical; Inc. Nov-26-2012 Cooper Surgical Advincula Arch – Cooper Surgical Advincula Arch ; Reusable Uterine Manipulator HandleRef: UMH750The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus; fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation; and/or operative laparoscopy Excessive pressure exerted on the uterine tip when attached to the Arch may; under certain circumstances; cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
Cooper Surgical; Inc. Nov-26-2012 Cooper Surgical RUMI Arch – Cooper Surgical RUMI Arch; Reusable Uterine Manipulator HandleRef: UMH700The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus; fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation; and/or operative laparoscopy Excessive pressure exerted on the uterine tip when attached to the Arch may; under certain circumstances; cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
Zimmer; Inc. Nov-26-2012 NexGen CompleteKnee Solution – NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial componentThe NexGen¿¿ system is a semiconstrained; nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion; dysfunction or prior patellectomy); moderate valgus; varus or flexion deformities; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Zimmer is initiating a lot specific recall of the NexGen? Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters.As a result; the devices may contain residual particulate from the manufacturing process.Risks include: Allergic reaction due to the foreign material or late onset
Biomet; Inc. Nov-27-2012 Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem – Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant)Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction offunctional deformity; 4) treatment of non-union; femoral neck fracture; and trochanteric fractures of the proximal femur with head involvement; unmanageable using other techniques; 5) revision of previously failed total arthoplasty. It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Metrex Research; LLC. Nov-27-2012 Pinnacle Cure Sleeve – Pentron Clinical Metrex Research; Pinnacle Cure Sleeve; a protective barrierThe intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms; body fluids and particulate matter. The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511; which fits 11mm light guides; actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
Terumo Cardiovascular Systems Corporation Nov-27-2012 100/120V AC; Advanced Perfusion System Platform (APS) – 100/120V AC; Advanced Perfusion System Platform (APS)The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop; with no safety system functionality; and the battery would not be activated. The user would be limi
Terumo Cardiovascular Systems Corporation Nov-27-2012 220/240V AC; Advanced Perfusion System Platform (APS) – 220/240V AC; Advanced Perfusion System Platform (APS)The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular System (TCVS) has received reports of a situation where usersexperienced a total loss of functionality for some System 1 units. The reports indicate that theunits went blank and shut down with no sign of power and battery backup did not initiate. Theresult is all pumps stop; with no safety system functionality; and the battery would not beactivated. The user would be
Iradimed Corporation Nov-28-2012 MRIdium MRI Infusion Sets – The brand name is MRidium Series 1000 MR Infusion Sets; Type 1058 MR IV Extension Set; Lot Code LBG001. The generic name is infusion administration set.Labeling indicates ~10 ml; Latex-free Infusion Set with Needle-free Port; One injection Port. Device is single use only; do not resterilize; and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park; FL 32792. Lot LBG001; Exp 07/2016The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before; during; or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional; and not intended for any home use applications. Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets; Type 1058 MR IV Extension Set; Lot Code LBG001 because a section of the device does not meet specifications.
Medtronic Navigation; Inc. Nov-29-2012 Medtronic Navigation – The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling.. Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.
GE Healthcare; LLC Nov-29-2012 GE Healthcare – GE Healthcare Optima XR 200 amx with Digital Upgrade.The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx;Optima XR200amx; Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR); however the Optima XR22Oamx utilizes the GE Wireless Detector; which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures; for digital radiography (DR). GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product; Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
GE Healthcare; LLC Nov-29-2012 GE Healthcare – GE Healthcare Optima XR 220amx 15kw Mobile X-Ray SystemThe GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx;Optima XR200amx; Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR); however the Optima XR22Oamx utilizes the GE Wireless Detector; which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures; for digital radiography (DR). GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product; Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
GE Healthcare; LLC Nov-29-2012 GE Healthcare – GE Healthcare Optima XR 220amx 30kw Mobile X-ray SystemThe GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx;Optima XR200amx; Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR); however the Optima XR22Oamx utilizes the GE Wireless Detector; which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures; for digital radiography (DR). GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product; Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Kimberly-Clark Corporation Nov-29-2012 Kimberly-Clark Patient Warming System – Kimberly-Clark Patient Warming System – Model 1000 Control UnitThe product is a thermal regulating system; indicated for monitoring and controlling patient temperature. Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.