Device product
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Z-1391-2018
Product summary
- Event
- Event 79628
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-1391-2018
Official wording
Reason: While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Code information: Model Number GMR40. Serial numbers 00001 through 00016.
Distribution pattern: US Distribution . Only one consignee was shipped 16 units of the affected device.
Derived failure modes
-
Unknown
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.