Device recall
Z-2990-2011: DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to…
FDA device recall · Class II · Sunrise Medical HHG Inc. dba DeVilbiss Healthcare
Key facts
| Recall number (Z-number) | Z-2990-2011 |
|---|---|
| Recall event | 59042 |
| Product | DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated… |
| Product code | BZD |
| Recalling firm | Sunrise Medical HHG Inc. dba DeVilbiss Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2016 |
| 510(k) numbers | K071689 |
| 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