BEUDAMED
    FDA Enforcement Class II Terminated

    Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    Recall: Z-1728-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1728-2014
    Event ID
    68431
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Medical Immaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    May 29, 2014
    Classification Date
    June 6, 2014
    Termination Date
    March 31, 2017
    Address
    Suite 130-10711 Cambie Road, N/A, Richmond, British Columbia, N/A, Canada

    Description

    Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    Reason

    Firm received a complaint that an unreported study performed that day could not be opened from the archive.

    Code Info

    HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0

    Distribution

    Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.

    Quantity

    659