Device product
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
Z-2112-2016
Product summary
- Event
- Event 74511
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2112-2016
Official wording
Reason: Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.
Code information: 911162
Distribution pattern: Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Derived failure modes
-
Unknown
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.