BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

    Recall: Z-1900-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1900-2019
    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 biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

    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: 121013 121057 121056 121058 121006 121185 121016 121027 121020 121321 121448 121040 121049 121015 121094 121082 121089 121383 121144 121319 121137 121085 121155 121193 121136 121165 121140 121141 121151 121168 121169 121154 121211 121188 121415 121183 121209 121187 121309 121200 121313 121206 121361 121366 121359 121393 121301 121407 121406 121352 121379 121364 121342 121471 121520 121411 121412 121402 121430 121502 121421 121472 121460 121457 121515 121444 121516 121510 121491 121525 121530 121527

    Distribution

    Nationwide

    Quantity

    73