Recall Z-0005-2010 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Ge Healthcare
GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
| Date | Jan 20, 2010 (initiated Aug 12, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 1411 units total |
| Distribution | Nationwide and Canadian Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.