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

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.

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•

Inability to take a Digital Cine shot

• Warning tone (beep) fails to activate

A GEHC Surgery field service engineer will be contacting your
facility to remove the four (4) pedal footswitch and to install the
appropriate 2 or 3 pedal footswitch.

Solution:
At this time GEHC Surgery will not be offering a replacement for the 4 pedal footswitch for use with the

OEC® 9800, OEC® FluoroTrak 9800 Plus, OEC® 9800 Plus, and OEC® 9800MD Motorized C-arm
System, OEC® 9900 Elite Fluoroscopy Systems, 9900 EliteMD Motorized C-arm System. Users will
have the functionality previously available via the four (4) pedal footswitch by utilizing the 2 or 3 pedal
footswitch combined with the hand switch.

If you have any questions or concerns regarding these issues, please do not hesitate to contact the
service team for further information at 800-874-7378 option 8. Information is available at this
number 24 hours per day, 7 days a week.

Thank you,

Pete McCabe

President and CEO

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