Device recall
Z-2442-2018: Health Harmony Mobile application software Product Usage: Care Innovations…
FDA device recall · Class II · Intel-GE Care Innovations LLC
Key facts
| Recall number (Z-number) | Z-2442-2018 |
|---|---|
| Recall event | 80382 |
| 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… |
| Product code | OUG |
| Recalling firm | Intel-GE Care Innovations LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2020 |
| FEI number | 3008850109 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database