Device recall
Z-1750-2015: Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
FDA device recall · Class II · ResMed Ltd.
Key facts
| Recall number (Z-number) | Z-1750-2015 |
|---|---|
| Recall event | 71100 |
| Product | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. |
| Product code | CBK |
| Recalling firm | ResMed Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2016 |
| 510(k) numbers | K133868 |
| FEI number | 3004604967 |
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