BEUDAMED
    FDA Recall Terminated

    Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.

    Recall: Z-2312-2008 · Initiated May 1, 2008

    Recall

    Recall Number
    Z-2312-2008
    Event Number
    48738
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 1, 2008
    Posted
    September 20, 2008
    Terminated
    December 11, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.

    Reason

    GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.

    Action

    Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.

    Distribution

    AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Algeria Argentina Australia Austria Belgium Bosnia Brazil Bulgaria Byelorussian SSR Canada Chile China Columbia Croatia Cyprus Czech Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Guadeloupe Guatemala Guyana Honduras Hungary India Indonesia Iran Ireland Israel Italy Jamaica Japan Korea Kuwait Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macedonia Malaysia Mexico Morocco Netherlands New Zealand Norway Oman Pakistan Panama Paraguay Peru Philippines Poland Portugal Puerto Rico Puerto Rico Romania Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Thailand Trinidad Tunisia Turkey Ukraine United Aran Emirates United Kingdom Uruguay Venezuela Vietnam Yugoslavia

    Quantity

    5,249 (2,104 US/ 3,145 OUS)