BEUDAMED
    FDA Recall Terminated

    Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.

    Recall: Z-1181-2013 · Initiated March 15, 2013

    Recall

    Recall Number
    Z-1181-2013
    Event Number
    64833
    Firm
    Vital Images, Inc.
    FEI Number
    3001654007
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 15, 2013
    Posted
    April 26, 2013
    Terminated
    April 8, 2015
    Address
    5850 Opus Pkwy, Ste 300, Minnetonka, MN, 55343-4411

    Description

    Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.

    Reason

    Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.

    Action

    Consignees were sent on 3/15/2013 a VITAL Images, Inc., "Urgent Field Safety Notice" dated March 15, 2013. The letter described the problem and the product involved in the recall. The letter listed the limitations of the product and the steps to take. Consignees were requested to return the Product Recall Effectiveness Check form. Questions should be directed to Vital Images Customer Support at 1-800-208-3005 or via e-mail, [email protected].

    Distribution

    Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GREECE, GUAM, HONDURAS, HONG KONG, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.

    Quantity

    1,978