Reported May 23, 2018 · Terminated
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
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 Force (Model 10742326) Computed tomography x-ray diagnostic system
- Lot codes and dates
- Serial Numbers
91 of 91 codes
757087576575714757907570975607757847578975617755507552675512757757556775536758077571175716755147577075600757947556375824757687551075792754547575475755755407573975806758087557175818754377550075527757767572875475755357582075727754817543975450754827576075710754607547675588754937545875528754677582375761
- Serial Numbers
- Amount recalled
- 91
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
Why it was recalled
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
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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