Reported Jan 19, 2022 · Ongoing
SOMATOM Edge Plus-Computed tomography system Model 1026700
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-Computed tomography system Model 1026700
- Lot codes and dates
- Serial Numbers
80 of 80 codes
122022122185122098122062122099122121122146122054122082122080122020122164122116122008122036122029122044122172122074122075122049122194122141122167122156122183122081122126122129122090122130122179122089122085122037122009122163122177122066122064122038122161122132122171122153122168122158122144122063122086122035122041122112122114122107122101122108122109122162122187
- UDIUDI 04056869006949
- Serial Numbers
- Amount recalled
- 80 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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.
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