Device product
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Z-1922-2020
Product summary
- Event
- Event 85513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1922-2020
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 # 200044 Additional unit as off 5/22/20: 200026
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.