Recall Z-0989-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
| Date | Jul 12, 2007 (initiated Jul 6, 2007) |
| Status | Terminated |
| Reason | The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions. |
| Root cause | Other |
| Action | Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available. |
| Quantity | 22 units |
| Distribution | Worldwide, including USA, France, Singapore, Sweden, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041931 | OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION Ge Oec Medical Systems, Inc., Aug 26, 2004 |