Fisher & Paykel Healthcare recalls Airvo 3 respiratory devices with software versions 1.2.0 or 1.5.1 that may deliver room air instead of oxygen during flow alignment alarms, risking hypoxia. Affected units sold in hospitals and facilities.
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.
Fisher & Paykel Healthcare is recalling Airvo 3 respiratory devices with specific software versions that could deliver room air instead of oxygen if a flow alignment alarm triggers. This risk of oxygen desaturation could lead to hypoxia in patients using the device.
The software issue causes the device to switch to room air delivery when a flow alignment alarm occurs. This can lead to oxygen desaturation, where patients may experience hypoxia (low oxygen levels) if the device fails to provide adequate oxygen.
Patients using the Airvo 3 respiratory device in hospitals or medical facilities with software versions 1.2.0 or 1.5.1 are most at risk. Healthcare providers managing these devices should check their software versions.
Check for software versions 1.2.0 or 1.5.1 on the Airvo 3 device. The device model number is PT301US and it was sold in hospitals and medical facilities.
Verify the software version on your Airvo 3 device; affected units have versions 1.2.0 or 1.5.1.
Software versions 1.2.0 and 1.5.1 are affected.
The device may deliver room air only instead of oxygen, potentially causing oxygen desaturation and hypoxia in patients.
Check the software version on your Airvo 3 device; affected units have versions 1.2.0 or 1.5.1.
We’ve drafted a message you can send Fisher & Paykel Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3262-2024 — Fisher & Paykel Healthcare Fisher & Paykel Healthcare Hello, I own a Fisher & Paykel Healthcare that is covered by recall Z-3262-2024 from Fisher & Paykel Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
