Recall Z-1884-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
OEC Medical Systems, Inc
GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.
| Date | Sep 25, 2008 (initiated Aug 12, 2008) |
| Status | Terminated |
| Reason | Beam limitation may be non-compliant on some X-ray units. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Consignees were notified by letter on 08/12/2008. GE service representatives will check proper beam compliance on next scheduled maintenance visit or will schedule a visit to address the issue. Information available at 1-800-874-7378. |
| Quantity | 201 systems |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 20, 2003 |