BEUDAMED
    FDA Enforcement Class II Terminated

    ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

    Recall: Z-1144-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1144-2021
    Event ID
    87169
    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 3, 2021
    Initiation Date
    December 18, 2020
    Classification Date
    February 23, 2021
    Termination Date
    November 17, 2021
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

    Reason

    Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system

    Code Info

    Software version VE20B. Serial Numbers: Serial 180054 180062 180019 180065 180056 180057 180041 180084 180034 180072 180060 170026 180070 180048 180083 180080 180067 180040 180029 170023 180068 170025 180018 180047 180046 180085 180035 180081 170051 170027 180043 170053 180049 180077 180053 180055 180015 180014 180066 180082 180037

    Distribution

    US Nationwide distribution.

    Quantity

    41 U.S