Reported Jul 25, 2018 · Terminated
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a…
Intel-GE Care Innovations LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intel-GE Care Innovations LLC · 3721 Douglas Blvd Ste 100 · Roseville, CA · 95661-4243
Is this the product you have?
- Health Harmony Mobile
- application software Product UsageCare 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
- Lot codes and dates
- Version v 2.5.2.29
- Amount recalled
- 1302
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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