BEUDAMED
    FDA Recall Terminated

    GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

    Recall: Z-0008-2011 · Initiated August 30, 2010

    Recall

    Recall Number
    Z-0008-2011
    Event Number
    56599
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 30, 2010
    Posted
    October 6, 2010
    Terminated
    September 13, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

    Reason

    Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila

    Action

    GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. 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, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.

    Distribution

    Worldwide Distribution: USA: All States, including DC, except Delaware, and the countries of YEMEN, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI, ARABIA, RUSSIA, PORTUGAL POLAND, PERU, PANAMA, NORWAY, NETHERLAND, MACEDONIA, LITHUANIA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, IRELAND, INDIA, HUNGARIA, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.

    Quantity

    3039