BEUDAMED
    FDA Enforcement Class II Terminated

    Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392

    Recall: Z-0708-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0708-2018
    Event ID
    79097
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    June 6, 2017
    Classification Date
    February 23, 2018
    Termination Date
    May 16, 2019
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392

    Reason

    Potential for liquid entry

    Code Info

    10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392

    Distribution

    U.S. Nationwide

    Quantity

    N/A