Home / Recalls / Medical Devices
Intel-GE Care Innovations LLC recalls Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a c
Recalled July 25, 2018 · FDA recall Z-2442-2018 · Intel-GE Care Innovations
Hazard
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. · FDA Class II
Units
1302
Sold at
US Nationwide Distribution in the states of CO, ID, PA, and LA
Description
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.
Product
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.
Manufacturer(s)
Intel-GE Care Innovations LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →