FDA-Device2021-12-01Class II
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Siemens Medical Solutions USA, Inc
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
Sold states
US Nationwide distribution.
Affected count
298 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0285-2022Don't want to check this manually?
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