June 2, 2004

Item: Minor Surgery/Exam lights: CoolSpot™ and Outpatient® Fleximount™
Single Ceiling and Track Mount with Single Trolley manufactured by
Burton Medical before August 2000. Specific model numbers are 0100540,
0100740, 0100580, 0102180 and 0102540.

Specific Incident: Due to an inherent weakness in the original
composition of the pivot support casting, the pivot joint can fail and
the light may fall onto a patient. These lights are typically found in
areas where minor surgeries, exams and/or procedures are performed.

Action: If you have not already done so:

> 1\. Review Burton Medical's notice (attached and available on-line at
> <http://www.burtonmedical.com/safetyNote.htm>).
>
> 2\. Identify and inspect all units affected by this alert for cracked
> pivot supports, and complete Burton Medical\'s form to obtain new
> pivot supports and arms.

3.  For identified lamps with cracked pivot supports - If possible,
    remove them from service. Otherwise:

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a.  Users: Inspect each light daily before use for normal movement and
    stability. If the light appears loose or unstable, contact
    Engineering to have it checked.

b.  Engineering: Inspect identified lights every two weeks until new
    components are installed.

Addl Information: Please contact CEOSH if you are affected and did not
receive Burton Medical\'s original letter.

Source: CEOSH, FDA and Manufacturer

Contact: Sharon Anderson, Customer Service, Burton Medical at

\(800\) 444-9909 X164.

Paul Sherman, VA Center for Engineering & Occupational Safety and Health
(CEOSH) at (314) 543-6712

March 2004

**URGENT NOTICE:**

**MEDICAL DEVICE SAFETY CORRECTION PROGRAM**

To: Users of Burton Medical Products CoolSpot™ and Outpatient®
Fleximount™ ***Single Ceiling*** ***and*** ***Track Mount with Single
Trolley*** (Model #'s 0100540, 0100740, 0100580, 0100780, 0102180 and
0102540) ***manufactured prior to August 2000.***

From: Wayne Okazaki

Quality Assurance Manager

Burton Medical Products

Re: Safety Replacement Program

Records supplied by our distributors indicate that you purchased one or
more of the pre-2000 models listed above that are covered by Burton's
SAFETY REPLACEMENT Program.

Due to an inherent weakness in the original composition of the pivot
support casting, the switch assembly and extension arm for your
Outpatient®/CoolSpot™ Fleximounts listed above should be replaced to
prevent any risk of the light falling or separating from the ceiling
mount. ***In keeping with a high quality standard, Burton Medical
products will replace all pivot support and extension arms for single
ceiling mount manufactured prior to August 2000.***

Please complete Attachment A and return to Burton Medical Products by
APRIL 30, 2004. If you need assistance, please contact Sharon Anderson
in Customer Service at (800) 444-9909 Ext. 164, fax to (800) 765-1770 or
email <sharona@burtonmedical.com>.

Notes:

1.  Units manufactured after July 2000 are not subject to this safety
    replacement. Pivot support-switch assemblies manufactured after July
    2000 incorporate a single machined pivot that inherently limits the
    risk of the lightheads separating from the ceiling mounts.

2.  Double Outpatient®/CoolSpot™ mounts are not subject to this safety
    replacement due to their pivot assembly design that inherently
    limits the rotation of the lightheads and prevents separation from
    the ceiling mount

# APRIL 2004 Log No. \_\_\_\_\_\_\_\_\_\_\_

# 

# ATTACHMENT A

# 

# URGENT MEDICAL DEVICE SAFETY CORRECTION

COOLSPOT^TM^ AND OUTPATIENT® FLEXIMOUNT^TM^ SINGLE CEILING AND FASTRAC
MOUNT WITH SINGLE TROLLEY (MODEL #'S 0100540, 0100740, 0100580, 0100780,
0102180 AND 0102540) MANUFACTURED PRIOR TO AUGUST 2000.
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of
Facility:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Contact
Person:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
\
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
\
Telephone:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Email: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

In order to determine if your unit(s) are affected by this Medical
Device Safety Correction, please inspect the Burton lights at your
facility and complete the following information (Quantity for both
categories is required in order to prevent processing delays):

Units with model #'s covered by Safety Correction that:

A. Look like the attached drawing and NEED REPLACEMENT:

> Serial Nos.
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> Qty. \_\_\_\_\_\_\_\_

B. Do not look like attached drawing and DO NOT APPEAR TO BE AFFECTED:

> Serial Nos.
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> Qty. \_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

After completing the above steps and information, please return to
Burton Medical Products via fax at (800) 765-1770. Please contact Sharon
Anderson, <sharona@burtonmedical.com>, at Burton within 30 days of the
date of this letter.

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