BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)

    Recall: Z-0857-06 · Initiated November 16, 2005

    Recall

    Recall Number
    Z-0857-06
    Event Number
    34050
    Firm
    GE Healthcare
    FEI Number
    2183066
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 16, 2005
    Posted
    May 9, 2006
    Terminated
    January 23, 2007
    Address
    3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, WI, 53718

    Description

    Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)

    Reason

    Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatment.

    Action

    Customers were sent a letter dated November 16, 2005, informing them of the possible alarm failure and giving them short term and long term solutions. Short term, clinicians are to: 1) check the audio alarm prior to use; and 2) use the ADU in conjunction with functioning anesthetic agent monitor. In the long term a GE Healthcare representative will contact the facility and schedule a visit to implement the corrective action at no charge.

    Distribution

    Worldwide---USA-States of AZ, CA, IA, MI, TX, and WI ----International- Australia, Austria, Belgium, Finland, Germany, Israel, Italy, Jordan, Malaysia, Netherlands, Norway, Portugal, Slovakia, South Africa, and Turkey.

    Quantity

    113---(USA-61--International-52)