Device product
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Z-1923-2020
Product summary
- Event
- Event 85513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1923-2020
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 860067, 860023
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.