BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

    Recall: Z-2318-2013 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-2318-2013
    Event ID
    66301
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Information Solutions LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    September 4, 2013
    Classification Date
    September 30, 2013
    Termination Date
    February 6, 2017
    Address
    5995 Winward Plaza, Information Technology Business, Alpharetta, GA, 30005, United States

    Description

    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

    Reason

    Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.

    Code Info

    Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.

    Distribution

    Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.

    Quantity

    329 units