Reported Jan 19, 2022 · Ongoing
SOMATOM Definition AS-Computed tomography system 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-Computed tomography system Model 8098027
- Lot codes and dates
- Serial Numbers
794 of 794 codes
962789688766027644926454164519644276729795303962676486496211598026724164798984236559795389966896441964347648606438264869652386673492078958049647198402959859671095889957789235395847959366723664464644716585295798964549646695363649279196698354959349627995807956029563965288647739522965297651596403695628
- UDIUDI 04056869003665
- Serial Numbers
- Amount recalled
- 794 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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