Device product
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Z-1921-2020
Product summary
- Event
- Event 85513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-1921-2020
Official wording
Reason: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Code information: Serial #s 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447, 100685, 100375, 100449, 100659, 100158, 100398 Additional serial number as of 5/22/20: 100117
Distribution pattern: Worldwide distribution including one unit distributed to Iowa.
Derived failure modes
-
Unknown
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.