Reported Dec 1, 2021 · Terminated
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
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 Edge Plus with software syngo.CT VB20 Model #10267000
- Lot codes and dates
- Serial NumbersSerial Number
63 of 63 codes
122022122098122062122099122121122146122054122082122080122020122164122116122008122036122029122044122172122074122075122049122141122167122156122081122126122129122090122130122089122085122037122009122163122064122038122161122168122158122144122063122086122035122041122114122107122101122108122109122162122125122011122052122034122057122145122147122106122061122051122166
- Serial NumbersSerial Number
- Amount recalled
- 64 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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