Device product
Brilliance iCT Computed Tomography X-ray system
Z-1695-2015
Product summary
- Event
- Event 71231
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1695-2015
Official wording
Reason: A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Code information: Model# 728306; Serial #'s: 85019 & 85023.
Distribution pattern: Internationally to the countries of China and Norway.
Derived failure modes
-
Unknown
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.