Class II

Medical Device Recall: NAEOTOM Alpha.Pro 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

2 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1242-2026

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.

Siemens Medical Solutions USA, Inc Medical Device Recall: NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | SafeCheck