Device recall
Z-1006-2007: ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the…
FDA device recall · Class II · Resmed Corporation
Key facts
| Recall number (Z-number) | Z-1006-2007 |
|---|---|
| Recall event | 37832 |
| Product | ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007. |
| Product code | BZD |
| Recalling firm | Resmed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 6, 2010 |
| 510(k) numbers | K033841, K041209 |
| FEI number | 1000115734 |
At a glance
- 1–9 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