BEUDAMED
    FDA Recall Terminated

    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.

    Recall: Z-1144-2013 · Initiated March 15, 2013

    Recall

    Recall Number
    Z-1144-2013
    Event Number
    64683
    Firm
    Vital Images, Inc.
    FEI Number
    3001654007
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 15, 2013
    Posted
    April 18, 2013
    Terminated
    February 27, 2015
    Address
    5850 Opus Pkwy, Ste 300, Minnetonka, MN, 55343-4411

    Description

    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.

    Reason

    Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.

    Action

    Vital Images sent an Urgent Field Safety Notice dated March 15, 2013, to all affected consignees. The letter described the problem and the product affected by the recall. Letter provided a series of steps to follow which included to cease use of the device and to send the signed enclosed Effectiveness Check form to [email protected] or fax to 1-952-540-3717. For questions customers were instructed to call Customer Support at 1-800-208-3005. For questions regarding this recall call 952-487-9500.

    Distribution

    Worldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, SWITZERLAND, TURKEY, UKRAINE, UNITED KINGDOM.

    Quantity

    102