Recall Z-2442-2018 ยท OUG Medical Device Data System
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 thi
| Date | Dec 6, 2017 |
| Status | Terminated |
| 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 fo |
| Quantity | 1302 |
| Distribution | US Nationwide Distribution in the states of CO, ID, PA, and LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.