Recall Z-2025-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system pr
| Date | Jul 18, 2012 (initiated Nov 19, 2007) |
| Status | Terminated |
| Reason | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure. |
| Root cause | Device Design |
| Action | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE Healthcare sent an"URGENT RECALL NOTICE" dated February 22, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 800-874-7378 for questions concerning this recall. |
| Quantity | 726 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM Ge Oec Medical Systems, Inc., Aug 18, 2004 |