Z-2442-2018Class II

Health Harmony Mobile application software

Name: Z-2442-2018 Health Harmony Mobile application software
Creator: Intel-GE Care Innovations LLC
Published: 2017-12-06
License: https://open.fda.gov/license/

Intel-Ge Care Innovations, LLC / initiated 2017-12-06 / Terminated

FDA source

Intel-GE Care Innovations LLC began a recall of Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device... on 2017-12-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2442-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-06
Posted: 2018-07-16
Terminated: 2020-10-23
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.
Product code: OUG Medical Device Data System
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.
FDA 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 in commerce: 1302
Distribution: US Nationwide Distribution in the states of CO, ID, PA, and LA
Product codes and lots: Version v 2.5.2.29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2442-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2442-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-16

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)