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UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555

March 5, 1998

**Addressees**:

All medical licensees.

**Purpose**:

The U.S. Nuclear Regulatory Commission is issuing this information notice to alert addressees to the occurrence of anincident involving an Isocam II, dual-headed nuclear medicine gamma camera, manufactured by Park Medical Systems ofQuebec, Canada. The reported failure mode under investigation poses a potential for a serious crushing injury to the patientor the technicians using the camera. It is expected that recipients will review the information for applicability to theirfacilities and consider actions, as appropriate, to ensure safety. However, suggestions contained in this information noticeare not NRC requirements; therefore, no specific action nor written response is required.

**Description of Circumstances:**

The Food and Drug Administration (FDA) issued a Safety Notice on February 13, 1998, to alert users of Isocam II single-head and Isocam II dual-headed nuclear medicine gamma camera systems of a possible design or manufacturing defect thatcould, cause structured failure and result in serious injury to the patient undergoing testing, or to other personnel using orservicing the camera. The FDA Notice is attached for your information. As indicated in that notice, Park Medical Systemsof Quebec, Canada, is no longer in business and, for this reason, owners of such cameras are asked to report anymalfunctions that could cause injury directly to the FDA. Owners are also urged to notify FDA of their possession of such acamera so that FDA may forward additional information on the camera as it becomes available.

The device is a radiation detector used to take images of patients injected with radiopharmaceuticals. It contains noradioactive material. The hazard involves physical injury from falling components, not radiation exposure.

This information notice requires no specific action or written response. If you have any questions about the information inthis notice, please contact the technical contact listed below.

(NUDOCS Accession Number 9802270150)

----

ATTACHMENT 1IN 98-09March 5, 1998  Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration9200 Corporate BoulevardRockville MD 20850

February 13, 1998

**FDA Safety NoticeFailure of Isocam II, Dual-headed Nuclear Medicine Gamma Camera**

TO:  Nuclear Medicine Imaging Facilities

FDA has recently become aware of a malfunction, with potential for serious injury, involving an Isocam II, dual-headednuclear medicine gamma camera (also available as a single-head system), manufactured by park Medical Systems ofQuebec, Canada. A stainless steel plate from a harmonic drive motor failed, causing an arm of the system to fall into thegantry housing of the device. No collimator was on the camera at the time and no patient or operator was injured.

The cause of this incident is under investigation by the U.K., Medical Devices Agency and Park U.K. We will report thefindings once they become known; but we are unable to offer any recommendation at this time.

Adverse event reports related to device malfunctions that could cause or contribute to a serious injury are usually submittedto the device manufacturer. As Park Medical Systems is no longer in business, adverse event reports on the Isocam IIcamera should be submitted to FDA. In addition, if you own or operate one of these systems, please notify the FDA, at theaddress below, so that we can forward new information to you.

Please also be advised that the Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities toreport deaths and serious illnesses and injuries associated with the use of medical devices. Practitioners should follow theprocedures established by their facility for such mandatory reporting.

We encourage you to report directly to MedWatch, FDA's voluntary reporting program, those problems and malfunctionsnot required to be reported under SMDA. You may report to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane (HF-2), Rockville, MD 20857.

If you own or operate one of these systems or if you have questions about the content of this letter, please contact PaulaSimenauer, CDRH, HFZ-510, Piccard Drive, Rockville, MD 20850, FAX 301-594-2968, or e-mail [email protected].