BEUDAMED
    FDA Recall Open, Classified

    ARTIS Pheno VE30A and VE40A, Model 10849000

    Recall: Z-1814-2026 · Initiated March 12, 2026

    Recall

    Recall Number
    Z-1814-2026
    Event Number
    98772
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 12, 2026
    Posted
    April 16, 2026
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.

    Distribution

    U.S. and O.U.S.

    Quantity

    73