FDA recall Z-1241-2026

Siemens Medical Solutions USA, Inc · Class II · device

Product

NAEOTOM Alpha.Prime 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

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

Key facts

Status
Ongoing
Initiation date
2025-12-19
Report date
2026-02-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1241-2026