BEUDAMED
    FDA Enforcement Class II Ongoing

    Artis zee floor MN, Model Number 10094142

    Recall: Z-0971-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0971-2022
    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 floor MN, Model Number 10094142

    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: 4056869010090; Serial Numbers: 140421 140115 140101 140205 140213 140204 140209 140219 140224 140218 140226 140221 140220 140206 140105 140423 140406 140422 140102 140214 140109 140202 140424 140114

    Distribution

    US Nationwide.

    Quantity

    24 systems