BEUDAMED
    FDA Recall Terminated

    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

    Recall: Z-2085-2014 · Initiated June 13, 2014

    Recall

    Recall Number
    Z-2085-2014
    Event Number
    68569
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 13, 2014
    Posted
    July 21, 2014
    Terminated
    September 7, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

    Reason

    Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.

    Action

    Consignees were sent on 6/13/2014 a GE Healthcare "Urgent Medical Device Correction" letter #36103, 36104 and 36105 dated June 6, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information. Consignees were advised to contact Technical Support at 800-558-7044 in regard to questions on this recall.

    Distribution

    Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.

    Quantity

    41,992 (20,509 US; 21,483 OUS)