BEUDAMED
    FDA Enforcement Class II Terminated

    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    Recall: Z-2257-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2257-2020
    Event ID
    85615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2020
    Initiation Date
    April 23, 2020
    Classification Date
    June 3, 2020
    Termination Date
    October 26, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    Reason

    Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient

    Code Info

    Serial Numbers: 180014 180015 180018 180019 180029

    Distribution

    AZ, IL, UT, WI

    Quantity

    5 US