Recall Z-1706-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
OEC Medical Systems, Inc
OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
| Date | Sep 1, 2008 (initiated Apr 15, 2008) |
| Status | Terminated |
| Reason | Use of existing four-pedal footswitch on a different machine may cause various operational errors. |
| Root cause | Device Design |
| Action | Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance. |
| Quantity | 25 units |
| Distribution | Nationwide, including one VA facility in FL. No military or foreign 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 |