medical Class II Updated 2018-07-25

Intel-GE Care Innovations LLC recalls Health Harmony Mobile application software Product Usage

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version v 2.5.2.29
View official government recall

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