BEUDAMED
    FDA Enforcement Class II Terminated

    Change Healthcare Radiology Solutions 14.0

    Recall: Z-0072-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0072-2021
    Event ID
    86401
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 14, 2020
    Initiation Date
    August 25, 2020
    Classification Date
    October 8, 2020
    Termination Date
    February 16, 2021
    Address
    10711 Cambie Rd Suite 130, N/A, Richmond, N/A, N/A, Canada

    Description

    Change Healthcare Radiology Solutions 14.0

    Reason

    Software defect which may potentially result in one or more images missing in a study

    Code Info

    All Model number 14.0 UDI (01)17540262030020(10)140000

    Distribution

    Domestic distribution to VT, MS, WV, NE

    Quantity

    5 devices