Drug recall
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to…
FDA recall event 95173 · Class II · Fisher & Paykel Healthcare, Ltd.
Key facts
| Event ID | 95173 |
|---|---|
| Recall numbers | Z-3262-2024 |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my… |
| Initiation date | Aug 7, 2024 |
| Report date | Oct 2, 2024 |
| City | Auckland |
| Country | New Zealand |
| FEI number | 3002806988 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: