OEC 9900 Elite
GE OEC 9900 Elite, OEC 9900 EliteMD, OEC 9900 EliteNAV, FlexiView 8800 Mobile C-Arm, OEC Miniview 6800 User manual
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DOC 0301686
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
April 13, 2007
To: Hospital Administrator
Director/Manager of Radiology
Subject: Product Safety Issues
Affected Products: OEC® 9900 Elite, OEC®, 9900 EliteMD Motorized C-arm System, OEC® OEC®
9900 Elite
NAV
, 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
Our records indicate that your facility has one or more of the following GEHC OEC products:
• OEC
®
9900 Elite
• OEC
®
9900 Elite
MD
Motorized C-arm System
• OEC
®
9900 Elite
NAV
• 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 previously identified and communicated intermittent potential safety issues that may
occur with the products listed above. The details and symptoms of these issues, as well as the
associated interim solutions, were described in the Recall Notification dated November 8, 2006. As the
result of the investigation of a reported incident, we are updating item 3 of that notification as
follows:
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