--- title: "PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or... — FDA record Z-3262-2024 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-3262-2024-pt301us-airvo-3-respiratory-support-device-with-software-version-1-2-0-and-or-1-5-1-the-airvo-3-is-i/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provid... — FDA record Z-3262-2024 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 7, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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**: 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. - **Classification**: Class II - **Recalling firm**: Fisher & Paykel Healthcare, Ltd. - **Quantity**: 944 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-3262-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3262-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers: | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution U.S.: 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 and WA. O.U.S.: Not provided States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [District of Columbia](https://isitonrecall.com/state/district-of-columbia/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Montana](https://isitonrecall.com/state/montana/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Washington](https://isitonrecall.com/state/washington/) ## Dates in the source - **Report date**: Oct 2, 2024 - **Recall initiation date**: Aug 7, 2024 - **Center classification date**: Sep 25, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3262-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fisher & Paykel Healthcare, Ltd. records](https://isitonrecall.com/brand/fisher-paykel-healthcare-ltd/)