Company:GE Healthcare
Date of Enforcement Report 2/3/2010
Class:ll

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

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.

RECALLING FIRM/MANUFACTURER
GE Healthcare, Salt Lake City, UT, by letter beginning October 5, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1395 units

DISTRIBUTION
Nationwide