PT301US Airvo 3 Respiratory Support Device with software version 1 — Class II medical device recall Z-3262-2024
Ongoing recall by Fisher & Paykel Healthcare, Ltd., reported 2024-10-02, distributed in AZ, CA, CO, CT, DC, FL, GA, IA…. Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignme
| Recall number | Z-3262-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher & Paykel Healthcare, Ltd., Auckland, New Zealand |
| Recall initiated | 2024-08-07 |
| Classified | 2024-09-25 |
| Reported by FDA | 2024-10-02 |
| Distributed | AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA, WA |
| Quantity | 944 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 09420012466662 |
| Serial numbers | PT301US |
| Model numbers | PT301US |
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.
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 experience oxygen desaturation that could lead to hypoxia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3262-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.