Health Harmony Mobile application software Product Usage: Care… — Class II medical device recall Z-2442-2018
Terminated recall by Intel-GE Care Innovations LLC, reported 2018-07-25, distributed nationwide. It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, t
| Recall number | Z-2442-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intel-GE Care Innovations LLC, Roseville, CA, United States |
| Recall initiated | 2017-12-06 |
| Classified | 2018-07-16 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2020-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,302 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2442-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.