BEUDAMED
    FDA Enforcement Class II Ongoing

    Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

    Recall: Z-1773-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1773-2021
    Event ID
    87891
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    April 19, 2021
    Classification Date
    June 2, 2021
    Address
    10711 Cambie Rd Suite 130, Richmond, N/A, Canada

    Description

    Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

    Reason

    A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.

    Code Info

    Software version 2.0 and 2.1.

    Distribution

    US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY.

    Quantity

    33 devices