Device recall
Z-0617-2009: DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low…
FDA device recall · Class II · Sunrise Medical
Key facts
| Recall number (Z-number) | Z-0617-2009 |
|---|---|
| Recall event | 50220 |
| Product | DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. |
| Product code | CAW |
| Recalling firm | Sunrise Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2012 |
| 510(k) numbers | K991722 |
| FEI number | 2515872 |
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