BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.

    Recall: Z-0968-04 · Initiated April 16, 2004

    Recall

    Recall Number
    Z-0968-04
    Event Number
    28936
    Firm
    Datex-Ohmeda Inc One Ohmeda
    FEI Number
    2183066
    Product Code
    CBN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 16, 2004
    Posted
    July 20, 2004
    Terminated
    November 14, 2005
    Address
    Dr. Box 7550, Madison, WI, 53707

    Description

    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.

    Reason

    Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.

    Action

    Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.

    Distribution

    The affected units were distributed nationwide in the United States and worldwide.

    Quantity

    73 units