GE OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800MD, OEC 9900 Elite 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
February 28, 2007 |
|
To: |
Director/Manager of Radiology |
Subject: |
Product Safety Issues |
Affected Products: |
OEC® 9800, OEC® FluoroTrak 9800 Plus, OEC® 9800 Plus, OEC® 9800MD |
|
Motorized C-arm System, OEC® 9900 Elite, OEC®, 9900 EliteMD Motorized C- |
|
arm System, OEC® 9900 EliteNAV, OEC® 8800 C-arm System |
Our records indicate that your facility has one or more of the following GEHC OEC products:
OEC® 9800
OEC® FluoroTrak 9800 PlusOEC® 9800 Plus
OEC® 9800MD Motorized C-arm SystemOEC® 9900 Elite
OEC® 9900 EliteMD Motorized C-arm SystemOEC® 9900 EliteNAV
OEC® 8800 System
GE Healthcare Surgery has identified two (2) potential safety issues with the systems listed above that have had either the x ray tube and/or the collimator replaced.
GEHC Surgery has identified two issues with the systems listed above that have had either the x ray tube and/or the collimator replaced. If your facility is receiving this notification our records indicate that your OEC® 9800, OEC® FluoroTrak 9800 Plus, OEC® 9800 Plus, OEC® 9800MD Motorized C-arm System, OEC® 9900 Elite, OEC® 9900 EliteMD Motorized C-arm System, OEC® 9900 EliteNAV, OEC® 8800, System may be affected by one or both of these issues.
The possible improper replacement of either the collimator or x ray tube may have resulted in a compromising of the beam limiting provisions on your system, therefore a potential exists for less effective
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