Fisher & Paykel Healthcare, Ltd.: Device Recall

Recall #Z-3262-2024 · 08/07/2024

Class II: Risk

Recall Details

Recall Number: Z-3262-2024
Classification: Class II
Product Type: Device
Recalling Firm: Fisher & Paykel Healthcare, Ltd.
Status: Ongoing
Date Initiated: 08/07/2024
Location: Auckland, New Zealand
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 944 units

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.

Product Description

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.

Distribution Pattern

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

Other Recalls by Fisher & Paykel Healthcare, Ltd.

Class II: Risk 09/18/2025

When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.

View all recalls by Fisher & Paykel Healthcare, Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.