BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1240-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1240-2026
    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 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: 11330003; UDI-DI: 04056869263168; Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313, 127272, 127275, 127276, 127206, 127118, 127152, 127091, 127183, 127166, 127125, 127264, 127220, 127104, 127037, 127136, 127201, 127137, 127221, 127205, 127176, 127297, 127245, 127138, 127314, 127310, 127195, 127259, 127093, 127085, 127215, 127235, 127208, 127256, 127036, 127180, 127242, 127115, 127290, 127146, 127039, 127315, 127203, 127071, 127170, 127318, 127273, 127101, 127046, 127133, 127246, 127083, 127240, 127241, 127299, 127068, 127224, 127139, 127251, 127119, 127265, 127311, 127185, 127111, 127112, 127102, 127249, 127266, 127280, 127132, 127227, 127277, 258044, 127142, 127289, 127075, 127144, 127130, 127131, 127080, 127124, 127271, 127169;

    Distribution

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

    Quantity

    88 units