FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare, Ltd.: 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 number
- Z-3262-2024
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- 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.
- Status
- Open, Classified
- Initiated
- 2024-08-07
- Posted
- 2024-09-25
- Terminated
- not on file
- 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.
- Root cause
- Software change control
- Action
- 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.
- Quantity
- 944 units
- 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
- Lot, serial or model codes
- Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:
- 510(k) numbers
- ["K221338"]
- PMA numbers
- not on file
- Product code
- QAV
- Firm FEI
- 3002806988
- Firm city
- Auckland
- Firm state
- East Tamaki
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28