Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Recall date
- December 19, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1242-2026
- FDA classification
- Class II
- Brand / firm
- Siemens Medical Solutions USA, Inc
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Why it was recalled
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Get recall alerts
Free email alert whenever Siemens Medical Solutions USA, Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Siemens Medical Solutions USA, Inc