Official recall record
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
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-08-07
- Country of alert
- New Zealand
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 09420012466662
- Brand on record
- Fisher & Paykel Healthcare, Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-09-18 · US FDA — Medical Devices
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 - 2024-04-02 · US FDA — Medical Devices
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
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