Reported May 8, 2019 · Terminated
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number…
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 with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode)
- Model Number 8098027 Product UsageComputed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
- Lot codes and dates
- Serial numbers of all affected models
122022100143100107838348374683811666491220208380112200812202983767838521000928379810009110011210012910013683837122023838711001171000971000991220098376383819837528384583846837498384710014683786838428377510009083796837688385910008783826837548379012201183824100147838108375810014010008583808
- Serial numbers of all affected models
- Amount recalled
- 53 total units distributed in U.S.
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
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
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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