BEUDAMED
    FDA Recall Terminated

    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.

    Recall: Z-2201-2013 · Initiated July 20, 2011

    Recall

    Recall Number
    Z-2201-2013
    Event Number
    66156
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 20, 2011
    Posted
    September 16, 2013
    Terminated
    October 25, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.

    Reason

    GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th

    Action

    Consignees were sent on 7/20/2011 a GE Healthcare "Important Product Information" letter. The letter was addressed to Healthcare Administrator / Risk Manager, chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Instructions, Product Correction, and Contact Information (Technical Support 1-800-558-7044).

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF SERBIA, PORTUGAL, POLAND, PARAGUAY, NORWAY, NETHERLANDS, NEPAL, MEXICO, MALAYSIA, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BOSNIA AND HERZEGOVINA, BELGIUM, BAHRAIN, AUSTRIA, and AUSTRALIA.

    Quantity

    636 (53 US, 583 OUS)