BEUDAMED
    FDA Recall Terminated

    GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information.

    Recall: Z-1600-2009 · Initiated March 10, 2009

    Recall

    Recall Number
    Z-1600-2009
    Event Number
    52002
    Firm
    GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226
    FEI Number
    3005860720
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    March 10, 2009
    Posted
    September 4, 2009
    Terminated
    October 16, 2012

    Description

    GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information.

    Reason

    GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.

    Action

    A GE Healthcare "Urgent Medical Device Correction" letter dated February 24, 2009 was sent to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Affected units will be replaced with new units by GE Field Service team members. For questions regarding this notice or experience a failure to restart the device, please contact GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.

    Distribution

    Worldwide Distribution -- US (states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD,KY, MI, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, WV and WI), AUSTRIA, AUSTRALIA, CANADA, CZECH REPUBLIC, GERMANY, EGYPT, SPAIN, FRANCE, GREAT BRITAIN, ITALY, POLAND and SWEDEN.

    Quantity

    352