Device product
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Z-1004-2017
Product summary
- Event
- Event 76021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1004-2017
Official wording
Reason: Failure to correctly document the installation of four M12 Bolts into the system rotor.
Code information: Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
Distribution pattern: The one system was distributed in Canada. There were no government or US distribution.
Derived failure modes
-
Unknown
Failure to correctly document the installation of four M12 Bolts into the system rotor.