BEUDAMED
    FDA Enforcement Class II Terminated

    Horizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).

    Recall: Z-2238-2012 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2238-2012
    Event ID
    62567
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Medical Imaging Group
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    May 29, 2012
    Classification Date
    August 21, 2012
    Termination Date
    September 12, 2013
    Address
    10711 Cambie Rdsuite 130, N/A, Richmond, British Columbia, N/A, Canada

    Description

    Horizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).

    Reason

    There is a potential to save reports in RadReport with an Incorrect Final Status.

    Code Info

    Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.

    Distribution

    Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.

    Quantity

    516 units