Recall Z-1302-06 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.
| Date | Sep 30, 2006 (initiated Aug 16, 2006) |
| Status | Terminated |
| Reason | X-ray systems could provide output which exceeds the 20 R/minute limit. |
| Root cause | Other |
| Action | Consignees were notified by certified letter on 08/14-15/2006. |
| Quantity | 8,266 units (US), 2,664 units (foreign) |
| Distribution | Worldwide |
| 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 |