Z-1242-2026 Class II Ongoing
FDA device recall Z-1242-2026 was initiated by Siemens Medical Solutions USA, Inc on December 19, 2025 and is designated Class II. Reason for recall: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. The recall status is ongoing. Affected quantity: 2 units.
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
NAEOTOM Alpha.Pro 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: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;