Siemens Medical Solutions USA, Inc. recalls Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Recalled Product
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Hazard / Issue
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Issued by
FDA
Distribution: Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
Lot/Code Info: 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)
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