BEUDAMED
    FDA Recall 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 · Initiated September 4, 2013

    Recall

    Recall Number
    Z-2318-2013
    Event Number
    66301
    Firm
    Mckesson Information Solutions LLC
    FEI Number
    3002684279
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    September 4, 2013
    Posted
    September 30, 2013
    Terminated
    February 6, 2017
    Address
    5995 Winward Plaza, Information Technology Business Alpharetta, GA, 30005

    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.

    Action

    Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.

    Distribution

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

    Quantity

    329 units