BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

    Recall: Z-1904-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1904-2019
    Event ID
    83082
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    June 6, 2019
    Classification Date
    June 28, 2019
    Termination Date
    February 9, 2021
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

    Reason

    Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

    Code Info

    Serial Numbers: 123049 123216 123046 123236 123211 123202 123043 123219 123240 123230 123246

    Distribution

    Nationwide

    Quantity

    11