BEUDAMED
    FDA Recall Open, Classified

    ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

    Recall: Z-1653-2026 · Initiated March 10, 2026

    Recall

    Recall Number
    Z-1653-2026
    Event Number
    98675
    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 10, 2026
    Posted
    April 7, 2026
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

    Reason

    During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.

    Action

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

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    U.S. 758, OUS 2077