BEUDAMED
    FDA Recall Terminated

    GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.

    Recall: Z-0363-2011 · Initiated October 5, 2010

    Recall

    Recall Number
    Z-0363-2011
    Event Number
    56461
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 5, 2010
    Posted
    November 15, 2010
    Terminated
    May 17, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.

    Reason

    Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer

    Action

    GE Healthcare issued an "Urgent Medical Device Correction" letter dated September 17, 2010 to consignees. The letter was addressed to Hospital Administrator, Head of Biomedical Engineering and Nursing Manager. The letter described the product, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Service representatives will updates all of the affected Transport Pros with PDM that were distributed. Customers may contact GE at 262-548-2731 about this correction.

    Distribution

    Worldwide Distribution: Domestic in the states of AL, AZ, AR, CA,CT, CO, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, and WY, and Internation in the countries of BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY GREECE, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MAURITIUS, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD 7 TOBAGO, and the UNITED KINGDOM.

    Quantity

    3256