Recall Z-0821-2007 ยท IZL System, X-Ray, Mobile
GE Medical Systems LLC
Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
| Date | May 22, 2007 (initiated Dec 21, 2006) |
| Status | Terminated |
| Reason | When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely. |
| Root cause | Other |
| Action | Visit to each consignee beginning December 21, 2006. |
| Quantity | 6 units |
| Distribution | Product was distributed in the following states: MS, NE, NJ, and, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052897 | GE DEFINIUM AMX 700, MODEL AMX 700 General Electric Medical Systems, Nov 8, 2005 |