GE FlexiView 8800 Mobile C-Arm, OEC UroView 2800, OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus 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 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® 9800MD Motorized 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-ArmOEC® Miniview 6800OEC® UroView 2800OEC® 9800

OEC® FluoroTrak 9800 PlusOEC® 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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