BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1653-2026 · Reported April 15, 2026

    Enforcement

    Recall Number
    Z-1653-2026
    Event ID
    98675
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    FDA Mandated
    Report Date
    April 15, 2026
    Initiation Date
    March 10, 2026
    Classification Date
    April 7, 2026
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    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.

    Code Info

    ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    U.S. 758, OUS 2077