BEUDAMED
    FDA Recall Open, Classified

    interventional fluoroscopic x-ray system

    Recall: Z-2021-2025 · Initiated May 15, 2025

    Recall

    Recall Number
    Z-2021-2025
    Event Number
    97135
    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
    May 15, 2025
    Posted
    June 27, 2025
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    interventional fluoroscopic x-ray system

    Reason

    In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

    Action

    Siemens Healthineers sent customers a Customer Advisory Notice dated May 15, 2025 informing customers of a potential issue with ARTIS pheno and ARTIS icono systems with the following model numbers: ARTIS pheno 10849000, ARTIS icono biplane 11327600, ARTIS icono ceiling 11328100, ARTIS icono floor 11327700; due to in very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose and appropriate software update will be implemented, based on the current software version of the affected system.

    Distribution

    Worldwide.