Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand
Lot Codes / Batch Numbers
Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:
Products Sold
Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand is recalling PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 08/13/2024, the firm sent an "Urgent: Medical Device Correction" Letter via email, phone, letter or face to face communication to inform customers that due to a software issue with the Airvo 3 (software version 1.5.1 or earlier) when the flow alignment alarm 3.2.2 occurs, Airvo 3 devices set up with high pressure oxygen the device will deliver room air only. Patients may experience oxygen desaturation that could lead to hypoxia. For Distributors - Actions required for affected products are: Step1-Identify affected products using Model Number reference (REF), Serial Number (SN) and Manufacturing Date (YYYY-MM-DD). If the device is still within your inventory, put the product in quarantine to prevent ongoing distribution until Fisher&Paykel (F&P) Healthcare has contacted you with next steps. Step2-Complete and return the attached response form Step3-Await instructions from Fisher&Paykel Healthcare For healthcare facilities: Until the software is updated, the Airvo 3 device can continue to be used by your customers. When using the device, all instructions, including warnings and cautions in the Airvo 3 User Manual must be followed, particularly those in Sections 1 and 2. If alarm 3.2.2 occurs, follow the onscreen instructions. For questions/assistance - contact F&P Field Action Team via email at FieldAction.USA@fphcare.com or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, ND, OH, OR, PA, SD, TX, UT, VA, WA, DC
Page updated: Jan 10, 2026
Important Notice
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