BEUDAMED
    FDA Recall Open, Classified

    ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

    Recall: Z-2205-2026 · Initiated March 9, 2026

    Recall

    Recall Number
    Z-2205-2026
    Event Number
    98992
    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 9, 2026
    Posted
    June 4, 2026
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

    Reason

    During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

    Action

    Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026.

    Distribution

    US and Worldwide