Device recall
Z-1949-2014: DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep…
FDA device recall · Class III · DeVilbiss Healthcare LLC
Key facts
| Recall number (Z-number) | Z-1949-2014 |
|---|---|
| Recall event | 68393 |
| Product | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. |
| Product code | BZD |
| Recalling firm | DeVilbiss Healthcare LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 2, 2014 |
| 510(k) numbers | K071689, K091919 |
| 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