BEUDAMED
    FDA Enforcement Class II Ongoing

    McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

    Recall: Z-1682-2020 · Reported April 15, 2020

    Enforcement

    Recall Number
    Z-1682-2020
    Event ID
    85068
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2020
    Initiation Date
    February 10, 2020
    Classification Date
    April 8, 2020
    Address
    10711 Cambie Rd Suite 130, N/A, Richmond, British Columbia, N/A, Canada

    Description

    McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

    Reason

    Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

    Code Info

    McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2; Change Healthcare Software Versions: 14.1.1, 14.2

    Distribution

    Distribution US nationwide, Canada and the United Kingdom

    Quantity

    51 units