Device recall
Z-3262-2024: PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or…
FDA device recall · Class II · Fisher & Paykel Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-3262-2024 |
|---|---|
| Recall event | 95173 |
| Product | PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. |
| Product code | QAV |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K221338 |
| FEI number | 3002806988 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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