Recall Z-2442-2018— Intel-GE Care Innovations LLC

Class II FDA medical device recall by Intel-GE Care Innovations LLC, initiated 2017-12-06, terminated 2020-10-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm

Intel-GE Care Innovations LLC

Classification

Class II

Status

Terminated

Initiated

2017-12-06

Terminated

2020-10-23

Firm location

Roseville, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.