BEUDAMED
    FDA Enforcement Class II Terminated

    Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.

    Recall: Z-2089-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2089-2013
    Event ID
    65769
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MCKESSON TECHNOLOGIES INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 22, 2013
    Classification Date
    August 26, 2013
    Termination Date
    June 19, 2014
    Address
    5995 Windward Pkwy, Alpharetta, GA, 30005-4184, United States

    Description

    Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.

    Reason

    The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use.

    Code Info

    Model Number (software version) 8.0.2 & 8.0.1 with RapiDispense

    Distribution

    USA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.

    Quantity

    106