BEUDAMED
    FDA Recall Terminated

    GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    Recall: Z-0020-2009 · Initiated August 28, 2008

    Recall

    Recall Number
    Z-0020-2009
    Event Number
    49379
    Firm
    Datex - Ohmeda, Inc
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    August 28, 2008
    Posted
    October 6, 2008
    Terminated
    March 8, 2016

    Description

    GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    Reason

    The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.

    Action

    GE Healthcare "Urgent Medical Device Correction" letters dated 8/12/08 were sent on 8/20/08 individually to Health Administrator/Risk Manger, Head of Anesthesia and Director of Clinical Engineering. The letters described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The Safety Instructions state that the machines can be safely used as long as the following guidelines are followed: 1. Carry out the daily system checkout for any system in use. 2. The Aisys Anesthesia will alert the user both visually and audibly if it detects a fault condition. 3. Have an alternative method of anesthesia available at all times. Once each machine has been corrected an "Update" will be provided by the service technician responsible for the correction. Each customer/machine will receive a "GE Healthcare Urgent Medical Device Correction Update" letter which informs the customer that this correction is a follow-up activity to the letter that was sent earlier.

    Distribution

    Worldwide Distribution --- USA including states of AL, AK, CA, CO, FL, GA, IL, IN, KS, KY, ME , MD, MA, MI, MO, MT, NE, NV, NH, NY, NC, OH, OK, SC, SD, TX, VA, WV, WI, and DC, and countries of SOUTH AFRICA, TURKEY, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MEXICO, LIBYA, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, UNITED KINGDOM, FRANCE FINLAND, SPAIN, ESTONIA, DENMARK, GERMANY, COLOMBIA, CHINA, SWITZERLAND, CANADA, BRAZIL, BAHRAIN, BELGIUM, AUSTRALIA, AUSTRIA, and UNITED ARAB EMIRATES.

    Quantity

    1571