GE OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC FlexiView 8800 Mobile C-Arm User manual
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 21 2007 |
|
To: |
Hospital Administrator |
|
Director/Manager of Radiology |
Subject: |
Product Safety Issues |
Affected Products: |
OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC |
|
FlexiView 8800 Mobile C-Arm |
Our records indicate that your facility has one or more of the following GE Healthcare OEC (GEHC OEC) devices that has received a replacement hard disk drive:
OEC UroView 2800OEC 9800 Plus DigitalOEC MiniView 6800
OEC FlexiView 8800 Mobile C-Arm
GEHC OEC has discovered an issue with the hard disk drives that were installed on the above listed products during service calls. The manufacture dates of the affected hard disk drives are between October 15, 2004 and December 8, 2004
This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400 images. Systems may also fail to boot or lose patient data as this image capacity is approached.
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DOC0287403
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