BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It 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-2872-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2872-2016
    Event ID
    75194
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Medical Imaging Group
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    July 12, 2016
    Classification Date
    September 22, 2016
    Termination Date
    November 20, 2019
    Address
    10711 Cambie Rdsuite 130, Richmond, British Columbia, N/A, Canada

    Description

    McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It 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

    The STAT priority icon was not displayed in the Study List when the study was opened.

    Code Info

    McKesson Radiology versions 12.1.1 and 12.2

    Distribution

    Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland

    Quantity

    164 devices