Recall Z-0342-2009 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
OEC Medical Systems, Inc
GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
| Date | Jan 5, 2009 (initiated Aug 29, 2008) |
| Status | Terminated |
| Reason | Under certain conditions, x-ray system may experience operational impairment. |
| Root cause | Device Design |
| Action | Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378. |
| Quantity | 448 units |
| Distribution | Nationwide, including AK, KY, NC, VA WA. and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073542 | CYCLETRAC CT-5000 Pt Products, LLC, Feb 14, 2008 |