BEUDAMED
    FDA Recall Terminated

    CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

    Recall: Z-2275-2010 · Initiated July 16, 2010

    Recall

    Recall Number
    Z-2275-2010
    Event Number
    56141
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 16, 2010
    Posted
    August 25, 2010
    Terminated
    September 18, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

    Reason

    GE Healthcare has become aware of four potential safety issues associated with the CARESCAPE" Monitor B850: 1. Loss of user input when using certain displays or the USB remote control. 2. Potential for a delay in treatment or missed alarm when the alarm light is used as a primary alarm source and audible alarms are turned down or off. 3. The CARESCAPE Monitor B850 will not use user entered hemo

    Action

    Consignees were sent on 7/16/10, a GE "Urgent Medical Device Correction" letter dated July 12, 2010. The letter was addressed to Healthcare Administrator/Risk Manger, Chief of Nursing, Director of Biomedical Engineering. They stated the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. If you have any questions, please contact Technical Support at 1-800-558-7044.

    Distribution

    CA, CO, FL, GA, KY, LA, MA, MI, NE, NJ, NY, NC, OH, OR, PA, TX VA, and WI, Foreign: UNITED KINGDOM, TURKEY, SWITZERLAND, SPAIN , SLOVENIA, SINGAPORE, SAUDI ARABIA, PORTUGAL NETHERLAND, ITALY, GERMANY, FRANCE,FINLAND, DENMARK, CZECH REPUBLIC, BELGIUM, AUSTRIA, and AUSTRALIA.

    Quantity

    875