GE OEC Medical Systems, Inc began a recall of OEC 9800 Plus Fluoroscopic X-ray System on . The reason FDA records is "During routine service, a cover may have been installed without the required proper lead shielding". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0558-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- GE Healthcare
- Product
- OEC 9800 Plus Fluoroscopic X-ray System,
- Product code
- JAA System, X-Ray, Fluoroscopic, Image-Intensified
- Reason for recall
- During routine service, a cover may have been installed without the required proper lead shielding.
- FDA root cause
- Other
- Action
- Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
- Quantity in commerce
- 11 units of all models
- Distribution
- Nationwide to AL, AZ, IA, OH, TX, VA, and WV.
- Product codes and lots
- Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.
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