BEUDAMED
    FDA Enforcement Class II Ongoing

    Change Healthcare Radiology Solutions software version 14.2.2

    Recall: Z-0030-2026 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-0030-2026
    Event ID
    97545
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 8, 2025
    Initiation Date
    August 13, 2025
    Classification Date
    October 2, 2025
    Address
    10711 Cambie Rd Suite 130, N/A, Richmond, N/A, N/A, Canada

    Description

    Change Healthcare Radiology Solutions software version 14.2.2

    Reason

    Due to software issue, radiology reports may not be fully displayed when viewing.

    Code Info

    Version 14.2.2/UDI: (01)17540262030068

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.

    Quantity

    12 programs