Reported Feb 11, 2026 · Ongoing
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
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 X
- ceed Software applicationssyngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Lot codes and dates
- Material Number11330002
- UDI-DI04056869231051
- Serial Numbers
125205125250
- Amount recalled
- 2 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
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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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