BEUDAMED
    FDA Enforcement Class II Ongoing

    Artis Q.zen floor, Model Number 10848353

    Recall: Z-0978-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0978-2022
    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 Q.zen floor, Model Number 10848353

    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: 4056869010014; Serial Numbers: 105120 105110 105033 105032 105500 105105 105028 105503 105018 105114 105115 105026 105025 105135 105016 105119 105137 105501 105132 105128 105142 105017 105121 105122 105123 105100 105112 105124 105029 105030 105031 105125 Additional Serial Numbers as of 10/4/23: 143500

    Distribution

    US Nationwide.

    Quantity

    33 systems