Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel
- Recalling company
- Siemens Medical Solutions USA, Inc
- Product
- NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Reason
- To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 19, 2025
- Reported
- Feb 11, 2026
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- Status
- Ongoing
- Quantity
- 2 units
- Lot / codes
- Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
- Company location
- Malvern, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1242-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1242-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.