Device product
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Z-0955-2015
Product summary
- Firm
- GE Healthcare
- Event
- Event 70133
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-0955-2015
Official wording
Reason: A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Code information: Software version: 14MW14.29
Distribution pattern: US Distribution to the states of CA, FL, IL, NY, UT and WA.
Derived failure modes
-
Manufacturing or process control
quality control test was not performed