BEUDAMED
    FDA Recall Terminated

    Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.

    Recall: Z-0388-2012 · Initiated November 11, 2011

    Recall

    Recall Number
    Z-0388-2012
    Event Number
    60418
    Firm
    Vital Images, Inc.
    FEI Number
    3001654007
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 11, 2011
    Posted
    January 11, 2012
    Terminated
    December 3, 2013
    Address
    5850 Opus Parkway, Suite 300, Plymouth, MN, 55343-4414

    Description

    Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.

    Reason

    Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.

    Action

    Vital Images, Inc. sent an URGENT DEVICE RECALL letter dated November 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to inform all potential users of the issues. Customers were to be contacted by their Service Account Manager to discuss and schedule resolutions. For questions customers were to contact Vital Images Customer Support with any questions toll free at 1-800-208-3005, in Europe +31 (0) 70 4135801, in Asia t +86 10 8588 1800, or online at [email protected].

    Distribution

    Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of IRELAND, FRANCE, UNITED KINGDOM, SWITZERLAND, AUSTRALIA, SLOVENIA, GERMANY, NETHERLANDS, BELGIUM, PAKISTAN, BRAZIL, ARGENTINA, SWEDEN, QATAR, CHINA, FINLAND, ITALY, DENMARK, PORTUGAL, REPUBLIC OF KOREA, SPAIN, and CANADA

    Quantity

    338 (233 US)