PlainRecordsFDA · Medical device recall
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human… and 1 more product
- Date posted by the FDA
- Jan. 20, 2010
- Status
- Terminated
- Filed by
- Ge Healthcare
- 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.
- Distribution pattern
- Nationwide and Canadian Distribution
2 products in this recall
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy
- Product
- GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
- Quantity
- 1411 units total
- Codes and lots
- All associated serial numbers
- Recall started
- Aug. 12, 2009
- Device type
- System, X-Ray, Fluoroscopic, Image-Intensified
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0004-2010
GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy
- Product
- GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
- Quantity
- 1411 units total
- Codes and lots
- All associated serial numbers
- Recall started
- Aug. 12, 2009
- Device type
- System, X-Ray, Fluoroscopic, Image-Intensified
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0005-2010
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0004-2010, Z-0005-2010. The agency record governs; check it and the company before acting.