BEUDAMED
    FDA Enforcement Class II Ongoing

    NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

    Recall: Z-1241-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1241-2026
    Event ID
    98206
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2026
    Initiation Date
    December 19, 2025
    Classification Date
    February 3, 2026
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

    Reason

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

    Code Info

    Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;

    Distribution

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

    Quantity

    5 units