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 gas

Hazard

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.

Details from the source

Reason for recall: 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. 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 Quantity: 944 units Lot/code info: Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:

UPC codes

09420012466662

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.