Z-0893-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- March 11, 2022
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 devices
Product Description
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Reason for Recall
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Distribution Pattern
Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
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)