BEUDAMED
    FDA Recall Terminated

    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

    Recall: Z-1426-2009 · Initiated February 5, 2009

    Recall

    Recall Number
    Z-1426-2009
    Event Number
    51202
    Firm
    GE Healthcare
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 5, 2009
    Posted
    June 23, 2009
    Terminated
    December 10, 2011
    Address
    9900 Innovation Drive, Mail Stop: RP2138, Wauwatosa, WI, 53226

    Description

    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

    Reason

    Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h

    Action

    GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.

    Distribution

    Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.

    Quantity

    6243