BEUDAMED
    FDA Enforcement Class II Terminated

    Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

    Recall: Z-0695-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0695-2020
    Event ID
    84370
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2019
    Initiation Date
    November 14, 2019
    Classification Date
    December 17, 2019
    Termination Date
    May 12, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

    Reason

    In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.

    Code Info

    Model Number: 10094142 Serial Number: 140422, 140423, 140430 Software Version: VC21C

    Distribution

    US: WA and TX International: Denmark

    Quantity

    3