BEUDAMED
    FDA Recall Terminated

    NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.

    Recall: Z-1256-2010 · Initiated March 8, 2010

    Recall

    Recall Number
    Z-1256-2010
    Event Number
    54982
    Firm
    CareFusion
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 8, 2010
    Posted
    April 7, 2010
    Terminated
    July 5, 2012
    Address
    1850 Deming Way, Middleton, WI, 53562

    Description

    NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.

    Reason

    CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. This may result in the misinterpretation of the left versus right side of the brain. Users are being provided with instructions for removing these protocols and verifying that the deletion has been prop

    Action

    Consignees were sent a CareFusion "Urgent Medical Device Correction" letter dated March 3, 2010. The letter described the problem and product involved. The letter included "Action to be taken by Users," "Instructions for deleting protocols," and "Photos-Amplifier label and Headbox insert to be discarded". It also included a "Verification Form" to be completed by recipient. For questions, notify CareFusion-NeuroCare, Attention: Sue Niesen, at (800) 356-0007 ext. 5129, or via email at [email protected]

    Distribution

    All States in the United States including DC. UNITED ARAB EMIRATES, ALBANIA, ARGENTINA, AUSTRIA, AUSTRALIA, AZERBAIJAN, BANGLADESH, BELGIUM, BULGARIA, BAHRAIN, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECHOSLOVAKIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, EGYPT, SPAIN, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GREECE, GUAM, GERMANY, HONG KONG, HUNGARY, CRO ATIA, INDONESIA, IRELAND, ISRAEL, INDIA, ICELAND, ITALY, JORDAN, JAPAN, KOREA SOUTH, KWAI T, KAZAKHSTAN, LEBANON, LIECHTENSTEIN, LATVIA, MOROCCO, MALDOVA, MACEDONIA, MALTA, MAURITIUS, MEXICO, MALAYSIA, NIGERIA, NETHERLANDS, NORWAY, PANAMA, PERU, PHILIPPINES, PAKISTAN, POLAND, PUERTO RICO, PALESTINIAN TERRITORY, QATAR, ROMANIA, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVEN IA, SLOVAK REPUBLIC, THAILAND, TURKEY, TAIWAN, URUGUAY, UKRAINE, VENEZUELA, YEMEN, VI ET NAAM, YUGOSLAVIA, SOUTH AFRICA,

    Quantity

    2,984 US; 3,147 OUS