BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Radiology 12.2 - Picture Archive Communication System (PACS)

    Recall: Z-1396-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1396-2017
    Event ID
    76500
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Medical Imaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2017
    Initiation Date
    December 2, 2016
    Classification Date
    March 2, 2017
    Termination Date
    November 24, 2017
    Address
    10711 Cambie Rd Suite 130, N/A, Richmond, N/A, N/A, Canada

    Description

    McKesson Radiology 12.2 - Picture Archive Communication System (PACS)

    Reason

    Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status.

    Code Info

    Model 12.2

    Distribution

    AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT

    Quantity

    17