GE OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800MD, OEC 9900 Elite User manual

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DOC0295124

GE Healthcare

Pete McCabe

President and CEO

GE Healthcare, Surgery

384 Wright Brothers Drive

Salt Lake City, Utah 84116

U.S.A.

[e-mail]

Certified Mail Return Receipt Requested

URGENT RECALL NOTICE

PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVANT SYSTEM(S) OF

THESE ISSUES AND HOW TO ADDRESS THEM

March 21, 2007

To: Director/Manager of Radiology

Facility Administrator

Subject: Product Safety Issues

Affected Products: OEC® 9800, OEC® FluoroTrak 9800 Plus, OEC® 9800 Plus, and OEC®

9800MD Motorized C-arm System, OEC® 9900 Elite Fluoroscopy System,

9900 EliteMD Motorized C-arm System

Our records indicate that your facility has one or more of the products listed above that are being used in

conjunction with the four (4) pedal footswitch.

GE Healthcare has identified, through internal testing, the following potential safety issues that may occur

with the four (4) pedal footswitch.

These issues include:

• Stalling on boot up.

• Grainy or washed out images

• “X-RAY SWITCH STUCK” error on boot up with and x-rays are not allowed.

• Image automatically saving if the footswitch is plugged in after system has booted.

• Saving during auto x-ray could cause the technique to go to maximum momentarily

• Mode button will not function.

• The third pedal takes an HLF shot instead of a Digital Cine shot and you could get an XRAY

STUCK ERROR.