BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    Recall: Z-1825-2015 · Initiated March 12, 2015

    Recall

    Recall Number
    Z-1825-2015
    Event Number
    71449
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    IOL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 12, 2015
    Posted
    June 22, 2015
    Terminated
    September 29, 2017
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    Reason

    GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.

    Action

    General Healthcare sent an Urgent Medical Device Correction letter (GEHC Ref# 30074) dated March 12, 2015, to all affected consignees. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing and Healthcare Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, NEW ZEALAND, NICARAGUA, NEPAL, MYANMAR, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LEBANON, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HON GONG, GERMANY, FRANCE, FINLAND, ETHIOPIA, EGYPT, ECUADOR, DOMINICAN REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE , CAYMAN ISLAND , CANADA, CAMBODIA, BRUNEI DARUSSALAM, BRAZIL, BOLIVIA, BHUTAN, BANGLADESH, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.

    Quantity

    11,423 (5,540 units US, 5,883 units OUS