BEUDAMED
    FDA Enforcement Class II Terminated

    AXIOM Artis BC, Model Number 5904649

    Recall: Z-2015-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2015-2019
    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

    AXIOM Artis BC, Model Number 5904649

    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: 14101 14111 14108 14099 14094 14112

    Distribution

    US Nationwide Distribution

    Quantity

    6