—#85632

Product

GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: All associated serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.

Recalling firm

Firm: Ge Healthcare
Address: 384 Wright Brothers Dr, Salt Lake City, Utah 84116-2862

Distribution

Distribution pattern: Nationwide and Canadian Distribution

Timeline

Recall initiated: 2009-08-12
Posted by FDA: 2010-01-20
Terminated: 2012-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.