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.
