FDA-Device2022-04-13Class II
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Siemens Medical Solutions USA, Inc.
Hazard
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Sold states
Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
Affected count
7 devices
Manufactured in
2501 Barrington Rd, Hoffman Estates, IL, United States
Products
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0893-2022Don't want to check this manually?
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