Recall Z-1790-2012 ยท KPR System, X-Ray, Stationary
General Electric Med Systems LLC
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
| Date | Jun 8, 2012 (initiated May 31, 2006) |
| Status | Terminated |
| Reason | An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath |
| Root cause | Device Design |
| Action | GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels. |
| Quantity | 3,796 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |