FDA recall Z-0893-2022

Siemens Medical Solutions USA, Inc. · Class II · device

Product

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

Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.

Key facts

Status
Terminated
Initiation date
2022-03-11
Report date
2022-04-13
Termination date
2023-04-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hoffman Estates, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0893-2022