BEUDAMED
    FDA Recall Terminated

    GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company

    Recall: Z-0021-2007 · Initiated August 10, 2006

    Recall

    Recall Number
    Z-0021-2007
    Event Number
    36057
    Firm
    Datex Ohmeda, Inc
    FEI Number
    2183066
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2006
    Posted
    November 7, 2006
    Terminated
    February 24, 2008
    Address
    Po Box 7550, Madison, WI, 53707

    Description

    GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company

    Reason

    Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alrm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.

    Action

    Firm mailed recall letters on August 10, 2006, to consignees telling them what to do if a failure occurred during system checkout or during use, as a short term solution. Later, GE representatives will make visits to each site for modification of the interface valve on each device, as the long term solution.

    Distribution

    AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,

    Quantity

    471