BEUDAMED
    FDA Enforcement Class II Ongoing

    ARTIS Pheno VE30A and VE40A, Model 10849000

    Recall: Z-1814-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1814-2026
    Event ID
    98772
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    April 22, 2026
    Initiation Date
    March 12, 2026
    Classification Date
    April 16, 2026
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    ARTIS Pheno VE30A and VE40A, Model 10849000

    Reason

    During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

    Code Info

    UDI 04056869046877

    Distribution

    U.S. and O.U.S.

    Quantity

    73