BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    Recall: Z-1285-2015 · Initiated February 16, 2015

    Recall

    Recall Number
    Z-1285-2015
    Event Number
    70535
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    IOL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 16, 2015
    Posted
    March 17, 2015
    Terminated
    June 23, 2017
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    Reason

    Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.

    Action

    GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#30073 dated February 16, 2015. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing, & 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. UPDATE 3-30-2015: A second revised letter was sent on March 31, 2015. NOTE: this revised notification includes an update to the Affected Product Details section to include all revisions of power cords manufactured within the date range indicated. (The previous notification referenced only revisions B, C, & E).

    Distribution

    CONTINENTAL USA DISTRIBUTION INCLUDING DC AND PR. OUS: ARGENTINA AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BHUTAN, BOLIVIA, BRAZIL, BRUNEI, CAMBODIA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, SPAIN, FINLAND, FRANCE, UNITED KIGDOM, GERMANY, GUAM, GUYANA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITLAY, JAMAICA, JAPAN, REPUBLIC OF KOREA, MACAU, MALYAYSIA, MARTINIQUE, MEXICO, MONACO, MYANMAR, NEPAL, NEW ZEALANAD, NICARAGUA, PANAMA, PARAGUAY, PERU, PHILIPPINES, PORTUGAL, RUSSIA. SINGAPORE, SOUTH KOREA, SRILANKA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, URUGUAY, UZBEKISTAN, VENEZUELA, VIET NAM.

    Quantity

    13,345 (5,495 units US, 7,850 units OUS)