BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.

    Recall: Z-0009-2014 · Initiated September 16, 2013

    Recall

    Recall Number
    Z-0009-2014
    Event Number
    66381
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 16, 2013
    Posted
    October 15, 2013
    Terminated
    October 1, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.

    Reason

    GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv

    Action

    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated September 17, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager, and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US call 1 800-345-2700, for other countries contact your local GE Healthcare Service Representative).

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED KINGDOM, VIETNAM, URUGUAY, and VENEZUELA.

    Quantity

    10,263 (3,194 US, 7,069 OUS)