Device recall
Z-2036-2025: BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in…
FDA device recall · Class I · Philips Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-2036-2025 |
|---|---|
| Recall event | 96948 |
| Product | BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. |
| Product code | MNS |
| Recalling firm | Philips Respironics, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K113053 |
| FEI number | 2518422 |
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