BEUDAMED
    FDA Enforcement Class II Terminated

    Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

    Recall: Z-0997-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0997-2013
    Event ID
    64662
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    March 8, 2013
    Classification Date
    March 26, 2013
    Termination Date
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

    Reason

    The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.

    Code Info

    Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.

    Distribution

    Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.

    Quantity

    81