BEUDAMED
    FDA Enforcement Class II Terminated

    Artis zee multi, Model Number 10094139

    Recall: Z-2030-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2030-2019
    Event ID
    83203
    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 31, 2019
    Initiation Date
    June 12, 2019
    Classification Date
    July 22, 2019
    Termination Date
    September 18, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Artis zee multi, Model Number 10094139

    Reason

    A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

    Code Info

    Serial Numbers: 157435 157509 157660 157710 157458 130017 157698 157532 157449 157657 157136 157690 157616 157560 157436 157677 157528 157503 157615 157448 157165 157700 157602 157168 157642 157213 157164 157559 157156 157524 157588 157750 157579 157573 157650 157671 157554 157555 157521 157696 157488 157644 157648 157169 157668 157508 157510 157601 157139 158058 157536 157625 157600 157604 157565 157634 157635 157146 157583 157476 157497 157570 157658 157505 157594 157706 157586 157674 157414 157215 157692 157707 157507 157708 157544 157184 157659 157661 157531 157409 157688 157702 157704 157466 157442 157667 157438 157440 157645

    Distribution

    US Nationwide Distribution

    Quantity

    89