[pending] NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdens
Pending LLM rewrite. Source: FDA_DEVICE Z-1242-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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
- NAEOTOM Alpha.Pro 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: 10191100
- UDI-DI: 04068151014655
- Serial Numbers: 258043
- 258055
Distribution
Distributed nationwide across the United States.
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