Intel-GE Care Innovations LLC: 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.

Recall number

Z-2442-2018

Recalling firm

Intel-GE Care Innovations LLC

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.

Status

Terminated

Initiated

2017-12-06

Posted

not on file

Terminated

2020-10-23

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.

Root cause

Under Investigation by firm

Action

The firm sent e-mails to their 4 consignees during the first week of December 2017. with the following information: As you may know, we have discovered a technical issue in our Health Harmony product that may result in some patient data not being transmitted to the Maestro 2 clinical dashboard in a timely manner (i.e. vital signs, health session answers). This can also manifest as a patient unable to execute their health session. Our investigation shows that in some cases, your clinical team may not receive patient readings in the normal timeframe. We take this issue very seriously. We are focused on investigating the root cause while also mitigating the effects on patient management as our engineering team solves the issue. While we continue to investigate this issue, we are developing a mitigation and will begin deploying shortly. This includes a progress notice and a message on the patient tablet when the system is synchronizing and transmitting results. The message will remind patients to stay in the program until their results have successfully uploaded and transmitted. Please be assured we are urgently working on addressing this issue. Your Care Innovations program management team will follow up with you to discuss potential impact on your standard of care, the next steps and answer any questions you may have about this situation. Thank you for your continued patience, Marcus Grindstaff CHIEF OPERATING OFFICER Care Innovations Cell: 916.548.3013

Quantity

1302

Distribution

US Nationwide Distribution in the states of CO, ID, PA, and LA

Lot, serial or model codes

Version v 2.5.2.29

510(k) numbers

not on file

PMA numbers

not on file

Product code

OUG

Firm FEI

3008850109

Firm city

Roseville

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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