FDAHealthDecember 19, 2025
Siemens Medical Solutions USA, Inc — SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
⚠️ To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2025
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
What's affected?
- Product
- SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Lot code
- Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;
Additional details
Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.