BEUDAMED
    FDA Recall Open, Classified

    ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000

    Recall: Z-0119-2023 · Initiated September 20, 2022

    Recall

    Recall Number
    Z-0119-2023
    Event Number
    90904
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAA
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 20, 2022
    Posted
    October 21, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000

    Reason

    Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

    Action

    On September 20, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. This notification covered three issues. 1. System Error Management, in which the operator is unable to release X-Ray in "Bypass fluoroscopy" mode which remains permanently inhibited, and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Customers should ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. 2. Head Holder Symbols, in which the user cannot tell whether a head holder has been selected in the system, may lead to a collision between the C-Arm and the head holder during system movement if the head holder is being used but not selected on the system. Customers should ensure that the configuration of the head holder is correct prior to system movements and double check configuration in the control room in case of uncertainty during the procedure. 3. Stand Movement, in which rarely no stand movement is possible after a routine brake test, leading to a possible delay of procedure. Customers should carry out routine brake tests with sufficient time before starting any procedure. Siemens will correct the software errors and contact customers to arrange a date to perform the corrective action. Please feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436.

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    140 US