Z-1239-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- December 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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.
Distribution Pattern
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;