GE FlexiView 8800 Mobile C-Arm, OEC UroView 2800, OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus User manual
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GE Healthcare
Pete McCabe
President and CEO
GE Healthcare, Surgery
384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
Pete.mccabe@med.ge.com
Certified Mail Return Receipt Requested
URGENT RECALL NOTICE
PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVENT SYSTEM(S) OF
THESE ISSUES AND HOW TO ADDRESS THEM
November 8, 2006
To: Hospital Administrator
Director/Manager of Radiology
Subject: Product Safety Issues
Affected Products: FlexiView 8800 Mobile C-Arm, OEC® UroView 2800, OEC® 9800, OEC®
FluoroTrak 9800 Plus, OEC® 9800 Plus, OEC® 9800MDMotorized C-arm
System, and OEC® Miniview 6800
Our records indicate that your facility has one or more of the following GEHC OEC products:
FlexiView 8800 Mobile C-Arm
OEC®Miniview 6800
OEC®UroView 2800
OEC®9800
OEC®FluoroTrak 9800 Plus
OEC®9800 Plus
OEC® 9800MD Motorized C-arm System
GE Healthcare has identified several intermittent potential safety issues that may occur with these
products based upon feedback from some customers. The details and symptoms of these issues, as
well as the associated interim or permanent solutions, are outlined below.
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1. Navigation Tracking Inaccuracy:
Affected Products: OEC® FluoroTrak 9800 Plus
An issue has been discovered with the OEC® FluoroTrak 9800 Plus that could result in an
incorrect position of instrumentation versus the displayed reference image. This issue
could result in an injury to the patient due to incorrect anatomical
location of an instrument during a procedure.
Permanent Solution:
GE OEC is currently investigating corrective solutions. When a corrective solution has been
identified the GE OEC service team will contact your facility and arrange implementation of the
corrective action.
Users are advised to stop using the system WITH NAVIGATION until this
replacement has been successfully completed. OEC® FluoroTrak 9800
Plus system may be used as a standard C-Arm providing you review the
other issues as listed below.
2. System Lock Up:
Affected Products: FlexiView 8800 Mobile C-Arm, OEC® UroView 2800OEC® 9800OEC®
FluoroTrak 9800 PlusOEC® 9800 Plus, OEC® 9800MD Motorized C-arm System
GEHC OEC has become aware of a potential problem with the above-indicated products where
the C-arm may lock-up. Specifically, during system usage, the system may fail to function
(produce live x-rays), and the collimators may close. In addition, the system display may indicate
that the system is active (such as sound and/or light displays) when, in fact, the system is not
producing live x-rays. The left monitor of the system will not update (no live fluoroscopy). There
will be no radiation emission occurring despite the audible and visual indicators. If it is suspected
that the system has emitted an uncommanded radiation exposure the user should contact
GEHC to have the exposure logs reviewed to confirm if an exposure was made.
In critical clinical scenarios in which the C-arm is being used to make real-time therapeutic
decisions or guide real-time interventions, a system lock-up may cause a procedural delay.
Users should always be certain that the images shown on the Left Monitor are refreshing
and are in fact live x-ray images (one indicator of this status is that the word “live” displayed
on the screen).
Interim Solution:
Should your OEC System experience a Lock-up, restarting (rebooting) the system should restore
system functionality. The restarting (reboot) procedure for OEC 9800 Plus, OEC Flexiview 8800,
and OEC UroView 2800 will take less than 3 minutes. Images saved prior to the system
locking up will be restored and are retrievable. Images not saved prior to the system failure
will not be restored. At this time a corrective solution for the OEC 9800 Plus, OEC Flexiview 8800,
and OEC UroView 2800 is under investigation. Your facility will be notified as soon as a solution
has been identified.
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