Reported Dec 1, 2021 · Terminated
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
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 Edge with software syngo.CT VB20 Model #10590000
- Lot codes and dates
- Serial Numbers
297 of 297 codes
1554038401283047830958391583801155351155353838268375483904155521836328374315557883931839791553931553961554131554898323883336839848340184006838348356215534183564835821556068359615559615548515543783934837468323483971155573155335155422833321554591553828399483026833301555011555358328183767155600838808368315536015536115556483339
- Serial Numbers
- Amount recalled
- 298 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.