BEUDAMED
    FDA Recall Terminated

    Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.

    Recall: Z-1002-2013 · Initiated February 5, 2013

    Recall

    Recall Number
    Z-1002-2013
    Event Number
    64461
    Firm
    Vital Images, Inc.
    FEI Number
    3001654007
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 5, 2013
    Posted
    March 27, 2013
    Terminated
    May 8, 2015
    Address
    5850 Opus Pkwy, Ste 300, Minnetonka, MN, 55343-4411

    Description

    Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.

    Reason

    Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia

    Action

    Vital Images sent an "Urgent Field Safety Notice' letter dated February 5, 2013, to all affected customers. The letter identified the probelm the product and the action needed to be taken by the customer. Please immediately inform all potential users of Vitrea of the information contained in this letter. We recommend that all measurements associated with the error described in this letter be verified against results from other technologies. You will be contacted by Vital Images Customer Support or by the customer support department of your distributor to arrange for installation of this patch on your system. We recommend that you implement the patch. If you have an earlier version, Vital Images Customer Support or your distributor will contact you to discuss your options for replacement. Please sign this Notice in the space below to verify that you have received and understood it, and return your signed Notice by email to [email protected]. If you have questions, direct customers of Vital Images should contact Vital Images Customer Support at 1-800-208-3005 or by e-mail to [email protected]; customers through a distributor of Vital Images products should contact that distributor. Updated 5/28/2013: A second consignee Vital Images, Inc "Urgent Field safety Notice" letter dated March 26, 2013 was sent to consignees on 3/25/13. The follow-up letter was sent via e-mail and mail to 4,616 already-notified consginees, who had received affected versions 6.3.0, 6.2.3, or 6.1.6. The letter described the problem and the affected product being recalled and provided a number of steps to follow which included to retun the Effectiveness Check form.

    Distribution

    Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN.

    Quantity

    7649 (Expnaded 5/28/13 to 7654)