GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
FDA device recall Z-0005-2010 · posted 2010-01-20 · Terminated
Recall details
- Recalling firm
- Ge Healthcare
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 1411 units total
- Distribution
- Nationwide and Canadian Distribution
- Date initiated
- 2009-08-12
- Date posted
- 2010-01-20
- Date terminated
- 2012-04-23
- Location
- Salt Lake City, UT
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