BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

    Recall: Z-1897-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1897-2019
    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 zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

    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: 160335 160430 160368 160469 160357 160370 160369 160509 160427 160433 160443 160428 160429 160463 160001 160461 160486 160800 160487 160488 160507 160840 160862 160856 160823 160914 160930 161235 160401

    Distribution

    Nationwide

    Quantity

    29