Recall Z-1118-2009 ยท KPR System, X-Ray, Stationary
GE Healthcare, LLC
Definium 5000 X-ray System, model number 5220493 and 5220393-2
| Date | Sep 25, 2009 (initiated Mar 24, 2009) |
| Status | Terminated |
| Reason | A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems. |
| Quantity | 85 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063283 | DEFINIUM 5000 X-RAY SYSTEM Sedecal., Sa., Nov 17, 2006 |