Device recall
Z-1654-2022: Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for…
FDA device recall · Class I · Philips Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-1654-2022 |
|---|---|
| Recall event | 90695 |
| Product | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. |
| 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