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PRODUCT
1) GE OEC 9900 Elite ESP, to produce mobile fluoroscopic images of human anatomy. Recall # Z-0004-2010;
2) GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy. Recall # Z-0005-2010
CODE
All associated serial numbers
RECALLING FIRM/MANUFACTURER
GE Healthcare, Salt Lake City, UT, by letter beginning October 5, 2009. Firm initiated recall is ongoing.
REASON
A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
VOLUME OF PRODUCT IN COMMERCE
1,395 units
DISTRIBUTION
Nationwide |
