Roseville, CA, United States
Intel-GE Care Innovations LLC recalls
1 recall recorded since 2018, most recently on 6 December 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 6 December 2017
- Terminated
- 23 October 2020
- 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.
- Distribution
- US Nationwide Distribution in the states of CO, ID, PA, and LA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2442-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.