Intel-GE Care Innovations LLC recalls Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a commu…

Recall date

December 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2442-2018

FDA classification

Class II

Brand / firm

Intel-GE Care Innovations LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.