BEUDAMED
    FDA Enforcement Class II Terminated

    Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.

    Recall: Z-2442-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2442-2018
    Event ID
    80382
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intel-GE Care Innovations LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    December 6, 2017
    Classification Date
    July 16, 2018
    Termination Date
    October 23, 2020
    Address
    3721 Douglas Blvd Ste 100, Roseville, CA, 95661-4243, United States

    Description

    Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.

    Reason

    It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.

    Code Info

    Version v 2.5.2.29

    Distribution

    US Nationwide Distribution in the states of CO, ID, PA, and LA

    Quantity

    1302