BEUDAMED
    FDA Recall 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 · Initiated July 22, 2013

    Recall

    Recall Number
    Z-2089-2013
    Event Number
    65769
    Firm
    MCKESSON TECHNOLOGIES INC
    FEI Number
    3003781505
    Product Code
    BRY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 22, 2013
    Posted
    August 26, 2013
    Terminated
    June 19, 2014
    Address
    5995 Windward Pkwy, Alpharetta, GA, 30005-4184

    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.

    Action

    McKesson sent a Clinical Alert letter dated July 22, 2013 to all affected customers. The letter identified the affected product, symptoms, and actions to be taken. McKesson committed to releasing 8.0.2 Update 1.5 to affected customers which will include enhanced code to prevent the unhandled excpetion errors. Additional resolution steps were included in the letter. For questions call 1-800-700-8737.

    Distribution

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

    Quantity

    106