Device product
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Z-0893-2022
Product summary
- Event
- Event 89790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 devices
- Official record key
device-enforcement:Z-0893-2022
Official wording
Reason: There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Code information: A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510) B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354)
Distribution pattern: Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
Derived failure modes
-
Unknown
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.