Reported Dec 1, 2021 · Terminated
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
- Lot codes and dates
- Serial NumbersSerial Number
665 of 665 codes
962789688766027644926454164519644276729795303962676724164798984236559795389966896441964347648606438264869652386673492078958049647195889957789235395847959366723665852957989646695363649279835495934962799580795602956399598595229652976515964036956286614364317956109847495859959399560195070958829559695791
- Serial NumbersSerial Number
- Amount recalled
- 665 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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