BEUDAMED
    FDA Recall Terminated

    GE, 1009-9002-000 Avance Anesthesia Machine and Monitor

    Recall: Z-1527-2010 · Initiated March 12, 2010

    Recall

    Recall Number
    Z-1527-2010
    Event Number
    55355
    Firm
    Ge Healthcare, Llc
    FEI Number
    2126677
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 12, 2010
    Posted
    May 11, 2010
    Terminated
    January 30, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE, 1009-9002-000 Avance Anesthesia Machine and Monitor

    Reason

    Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.

    Action

    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

    Distribution

    Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.

    Quantity

    18 (4 USA, 14 OUS)