SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdens...
FDA Recall #Z-1239-2026 — Class II — December 19, 2025
Product Description
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Reason for Recall
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Code Information
Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated