Recall Z-3262-2024 ยท QAV High Flow/High Velocity Humidified Oxygen Delivery Device
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.
| Date | Sep 25, 2024 (initiated Aug 7, 2024) |
| Status | Open, Classified |
| 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 Manufac |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221338 | F&P Airvo 3 Fisher & Paykel Healthcare, Jan 27, 2023 |