BEUDAMED
    FDA Enforcement Class II Ongoing

    Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

    Recall: Z-0237-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0237-2024
    Event ID
    93259
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 15, 2023
    Initiation Date
    October 12, 2023
    Classification Date
    November 6, 2023
    Address
    10711 Cambie Rd Suite 130, Richmond, N/A, Canada

    Description

    Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

    Reason

    Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

    Code Info

    UDI/DI 17540262030020

    Distribution

    US, Canada, Ireland, Saudi Arabia, France, UK

    Quantity

    282 units