Recall Z-1789-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
General Electric Med Systems LLC
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
| 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
| K012389 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM Ge Medical Systems, Inc., Aug 10, 2001 |