Reported Oct 2, 2024 · Ongoing
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide…
Fisher & Paykel Healthcare, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fisher & Paykel Healthcare, Ltd. · 15 Maurice Paykel Place · Auckland · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Model NumberPT301US
- UDI-DI code09420012466662
- Lot/Serial Numbers—
- Amount recalled
- 944 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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