BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

    Recall: Z-1787-2012 · Initiated April 10, 2012

    Recall

    Recall Number
    Z-1787-2012
    Event Number
    61639
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 10, 2012
    Posted
    June 17, 2012
    Terminated
    July 9, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

    Reason

    GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m

    Action

    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 10, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer or Technical Support at 800-345-2700 for questions regarding this notification.

    Distribution

    Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.

    Quantity

    8