Device recall
Z-0746-2016: Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used…
FDA device recall · Class II · Resmed Corporation
Key facts
| Recall number (Z-number) | Z-0746-2016 |
|---|---|
| Recall event | 73071 |
| Product | Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is… |
| Product code | CBK |
| Recalling firm | Resmed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2016 |
| 510(k) numbers | K133868 |
| FEI number | 1000115734 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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