BEUDAMED
    FDA Enforcement Class II Ongoing

    McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

    Recall: Z-0128-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0128-2025
    Event ID
    95284
    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 23, 2024
    Initiation Date
    August 21, 2024
    Classification Date
    October 17, 2024
    Address
    10711 Cambie Rd Suite 130, Richmond, N/A, Canada

    Description

    McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

    Reason

    A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

    Code Info

    UDI Numbers: (01)80010939050010(10)130201, (01)80010939050027(10)140000. Versions Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.

    Quantity

    35 systems