BEUDAMED
    FDA Enforcement Class II Ongoing

    Change Healthcare Cardiology Hemo Software

    Recall: Z-2071-2025 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2071-2025
    Event ID
    97046
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    July 9, 2025
    Initiation Date
    May 22, 2025
    Classification Date
    July 2, 2025
    Address
    10711 Cambie Rd Suite 130, Richmond, N/A, Canada

    Description

    Change Healthcare Cardiology Hemo Software

    Reason

    Due to complaints, software update may cause software to unexpectedly shutdown.

    Code Info

    Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.

    Quantity

    29 systems