Reported May 8, 2019 · Terminated
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process…
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 Confidence
- Model Number 10590100 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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