Fisher & Paykel Healthcare, Ltd.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Fisher & Paykel Healthcare, Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-22FDA-DeviceClass IIAirvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
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.
- 2024-10-02FDA-DeviceClass IIPT301US 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.
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.
- 2024-05-22FDA-DeviceClass IIAirvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
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