BEUDAMED
    FDA Enforcement Class II Ongoing

    Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

    Recall: Z-1245-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1245-2022
    Event ID
    90184
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    April 11, 2022
    Classification Date
    June 7, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

    Reason

    if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

    Code Info

    UDI-DI: 04056869063317 Serial Number: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180060 180070 180048 180083 180315 180080 180301 180305 180067 180330 180040 180333 180029 180336 180316 180084 180334 180018 180046 180047 180335 180085 180035 180081 180331 180021 180321 180309 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037

    Distribution

    US Nationwide distribution.

    Quantity

    51 units