Device product
Brilliance CT 10 Air. 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.
Z-1654-2015
Product summary
- Event
- Event 71177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 153 units total
- Official record key
device-enforcement:Z-1654-2015
Official wording
Reason: The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Code information: System Code #, 728256, Serial #, 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036 & 30047.
Distribution pattern: Distributed in China.
Derived failure modes
-
Unknown
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.