Device recall
Z-0577-2015: Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a…
FDA device recall · Class II · Invacare Corporation
Key facts
| Recall number (Z-number) | Z-0577-2015 |
|---|---|
| Recall event | 69441 |
| Product | Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating… |
| Product code | CAW |
| Recalling firm | Invacare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2015 |
| 510(k) numbers | K020386 |
| FEI number | 1525712 |
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