Fisher & Paykel Healthcare Corp Ltd initiated a voluntary limited recall of batches of Airvo 2 and myAirvo 2 devices manufactured before August 14, 2017, according to a company news alert.
The voluntary limited recall relates to a speaker configuration issue that may result in distorted, intermittent or inaudible alarm sound levels. This does not affect the therapy delivered by the Airvo 2 or myAirvo 2 device and the devices will otherwise perform as intended. Beginning 14 August 2017, a new speaker configuration from a different supplier was implemented into the manufacturing of Airvo 2 and myAirvo 2 devices.
Airvo 2 and myAirvo 2 devices are used to deliver high-flow therapy to patients. The Airvo 2 and myAirvo 2 devices are not intended for life support and appropriate patient monitoring is required at all times. If there is an interruption to therapy a patient may experience oxygen desaturation.
Fisher & Paykel Healthcare is consulting with the various international regulatory authorities to initiate appropriate action in each country. The company will also be contacting distributors, dealers and hospitals that may have products subject to this recall and will replace any affected devices. The company estimates there are approximately 9,000 of the affected devices remaining in use.
Customers who have questions about the limited recall or require further information may contact their local Fisher & Paykel Healthcare representative, Fisher & Paykel Healthcare regional sales office, or distributor.
At this time the company estimates the costs associated with this limited recall will be approximately $12 million, which will be provisioned for in the company’s financial statements for the year ended March 31, 2024. When updated financial guidance was provided on March 22, 2024 the company did not anticipate or include this recall.