Recall Z-0559-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System,
| Date | Mar 22, 2007 (initiated Feb 9, 2007) |
| Status | Terminated |
| Reason | During routine service, a cover may have been installed without the required proper lead shielding. |
| 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 | 11 units of all models |
| Distribution | Nationwide to AL, AZ, IA, OH, TX, VA, and WV. |
| FDA record | Open on fda.gov |