BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-1787-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1787-2012
    Event ID
    61639
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    April 10, 2012
    Classification Date
    June 17, 2012
    Termination Date
    July 9, 2012
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    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

    Code Info

    Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969

    Distribution

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

    Quantity

    8