BEUDAMED
    FDA Enforcement Class II Ongoing

    Artis zee biplane MN, Model Number 10094143

    Recall: Z-0972-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0972-2022
    Event ID
    89860
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    February 23, 2022
    Classification Date
    April 21, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis zee biplane MN, Model Number 10094143

    Reason

    If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

    Code Info

    UDI: 4056869010106; Serial Numbers: 149100 149401 149421 149106 149202 149420 149402

    Distribution

    US Nationwide.

    Quantity

    7 systems