Device recall
Z-1532-2013: embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator…
FDA device recall · Class II · Embla System Llc
Key facts
| Recall number (Z-number) | Z-1532-2013 |
|---|---|
| Recall event | 65175 |
| Product | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and… |
| Product code | MNR |
| Recalling firm | Embla System Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2017 |
| 510(k) numbers | K073682 |
| FEI number | 3009448422 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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