Reported Dec 1, 2021 · Terminated
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
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 Flash with software syngo.CT VB20 Model #10430603
- Lot codes and dates
- Serial Numbers
121 of 121 codes
739177353173126986237306674909731527376098602986037347673726735867393798616742067354473648741567363674207738137436073054741287342798600736227362173424734237349373520737187329673471737867437498620738317404274191744057411774118736737349774929734097393573642742407365773090730307301373300734997353573655
- Serial Numbers
- Amount recalled
- 121 unit
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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