# FDA recall Z-2442-2018

> **Intel-GE Care Innovations LLC** · Class II · device recall initiated 2017-12-06.

## 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 for recall

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

## Key facts

- **Recall number:** Z-2442-2018
- **Recalling firm:** Intel-GE Care Innovations LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-06
- **Report date:** 2018-07-25
- **Termination date:** 2020-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Roseville, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2018

## Citation

> AI Analytics. FDA recall Z-2442-2018. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2442-2018. Source: US FDA. Licensed CC0.

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