Recall Z-0946-03 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems,Inc
Uroview 2500 X-ray System
| Date | Jun 21, 2003 (initiated May 12, 2003) |
| Status | Terminated |
| Reason | Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids. |
| Root cause | Other |
| Action | A Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units. |
| Quantity | 263 units |
| Distribution | Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914446 | UROVIEW 2000, MODIFICATION Oec-Diasonics, Inc., Jan 10, 1992 |