GE OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC FlexiView 8800 Mobile C-Arm User manual

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

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 2800
 OEC 9800 Plus Digital

 OEC 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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Your GEHC OEC Field Service Engineer will be contacting your facility to arrange to have a replacement
hard disk drive installed on your system.

Until a GEHC OEC Field Service Engineer has replaced the hard disk drive users should ensure that images
on the hard disk drive are stored via an alternate permanent media (film, long term storage) as the hard disk
drive approaches the 170 image capacity.

GEHC OEC is actively working to replace the affected hard disk drives in a timely manner. GEHC OEC
will, without charge, remedy this issue.

If you have any questions or concerns regarding these issues, please do not hesitate to contact the
service team for further information at 800-874-7378 option 8. Information is available at this number

24 hours per day, 7 days a week.

Thank you,

Pete McCabe

President and CEO

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