BEUDAMED
    FDA Recall Terminated

    Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354

    Recall: Z-1903-2019 · Initiated June 6, 2019

    Recall

    Recall Number
    Z-1903-2019
    Event Number
    83082
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 6, 2019
    Terminated
    February 9, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354

    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

    Action

    Siemens issued letter dated 6/6/19 advising of the problem, health risk and action to take: .Siemens is implementing a corrective action to all potentially affected users via Update Instruction AX023/18/S. Siemens Service organization will replace the screwed connection of the ceiling support according to specifications / instructions. In the event the bolt connection cannot be replaced due to technical conditions, the complete bearing will be replaced.

    Distribution

    Nationwide

    Quantity

    15