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Siemens Medical Solutions USA, Inc recalls SOMATOM Drive with software syngo.CT VB20 Model #10431700
Recalled December 1, 2021 · FDA recall Z-0287-2022 · Siemens Medical Solutions USA
Hazard
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur · FDA Class II
Units
75 units
Sold at
US Nationwide distribution.
Description
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
Product
SOMATOM Drive with software syngo.CT VB20 Model #10431700
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →