SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensiti
Pending LLM rewrite. Source: FDA_DEVICE Z-1239-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
The recalled product
- Product
- SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Material Number: 11330002
- UDI-DI: 04056869231051
- Serial Numbers: 125205
- 125250
Distribution
Distributed nationwide across the United States.
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