BEUDAMED
    FDA Recall Open, Classified

    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

    Recall: Z-0656-2021 · Initiated November 30, 2020

    Recall

    Recall Number
    Z-0656-2021
    Event Number
    87026
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 30, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

    Reason

    When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

    Action

    Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers via AX067/20/P on November 30, 2020. All modifications and repairs are provided to affected customers free of charge.

    Distribution

    Worldwide-US Nationwide

    Quantity

    5602