Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 2/3/2026
Class: II

PRODUCT:

SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Recall Number:

Z-1239-2026

REASON:

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

RECALLING FIRM/MANUFACTURER:

Siemens Medical Solutions USA, Inc

VOLUME:

2 units

DISTRIBUTION:

Worldwide distribution – US Nationwide and the countries of Canada, Costa Rica, India, Israel.