Class II

Medical Device Recall: NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Siemens Medical Solutions USA, Inc · December 19, 2025

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

88 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1240-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.