Company: Intel-GE Care Innovations LLC
Date of Enforcement Report: 7/25/2018
Class II:
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. Recall Number: Z-2442-2018
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/MANUFACTURER
Intel-GE Care Innovations LLC., Roseville, CA on 12/6/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1302
DISTRIBUTION
US Nationwide Distribution in the states of CO, ID, PA, and LA