BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0128-2025 · Initiated August 21, 2024

    Recall

    Recall Number
    Z-0128-2025
    Event Number
    95284
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    FEI Number
    3003757840
    Product Code
    DQK
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    August 21, 2024
    Posted
    October 17, 2024
    Address
    10711 Cambie Rd, Suite 130, Richmond 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.

    Action

    Change Healthcare notified consignees on about 08/21/2024 via emailed letter. Consignees were instructed to pay careful attention to the hemoglobin unit of measurement displayed on the top of the "results" screen of the Hemo application, communicate the issue to all relevant team members to ensure vigilance in data entry, ensure that the hemoglobin values are entered in the correct unit of measurement (mmol/l or g/dl) as configured in the Management Console and displayed at the top of the results screen, contact Change Healthcare support to schedule the deployment of the software update that addresses this issue. Additionally, consignees were requested to complete and return the response form. With regard to potentially affected data, Change Healthcare recommended consignees verify f the UOM setting for hemoglobin is configured to what users would expect, if the UOM settings are different than expected, contact Change Healthcare support for assistance with identifying when the UOM setting was changed, and which procedures were affected, and examine affected procedures and implement necessary corrective actions to rectify the data and address patient care concerns.

    Distribution

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

    Quantity

    35 systems