Device product
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Z-1774-2021
Product summary
- Event
- Event 87872
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units (1 US and 1 OUS)
- Official record key
device-enforcement:Z-1774-2021
Official wording
Reason: Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Code information: Serial Numbers: 100100, 100434
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Derived failure modes
-
Unknown
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury