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Recall Observatory FDA recall evidence

Device product

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Z-0893-2022

March 11, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
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

    reason.no_named_rule · v1.0.0

    There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.