Device recall
Z-1375-2013: QuietCare. Intended for use in monitoring the environmental conditions and…
FDA device recall · Class II · Intel-GE Care Innovations LLC
Key facts
| Recall number (Z-number) | Z-1375-2013 |
|---|---|
| Recall event | 65031 |
| Product | QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. |
| Product code | IQA |
| Recalling firm | Intel-GE Care Innovations LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2013 |
| 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