BEUDAMED
    FDA Enforcement Class II Terminated

    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system

    Recall: Z-1782-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1782-2013
    Event ID
    65651
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    June 26, 2013
    Classification Date
    July 22, 2013
    Termination Date
    February 5, 2015
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system

    Reason

    Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui

    Code Info

    Model numbers: 10094137, 10094139, 10094141, 10280959

    Distribution

    Nationwide Distribution and Puerto Rico

    Quantity

    29