Device product
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.
Z-1789-2012
Product summary
- Event
- Event 37654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,796 units
- Official record key
device-enforcement:Z-1789-2012
Official wording
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
Code information: All serial numbers
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
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