Fisher & Paykel Healthcare Corporation (ASX:FPH) has initiated a voluntary limited recall of batches of Airvo 1 and my Airvo 2 devices manufactured before August 14, 2017.
Fisher & Paykel Healthcare is a prominent developer, manufacturer, and marketer of products and systems used in acute and chronic respiratory care, surgery, and obstructive sleep apnea treatment.
The recall concerns an issue with the speaker configuration, which may result in distorted, intermittent, or inaudible alarm sound levels.
However, this issue does not affect the therapy provided by the Airvo 2 or myAirvo 2 device, and they will continue to function as intended.
Since August 14, 2017, a new speaker configuration from a different supplier has been incorporated into the manufacturing process of Airvo 2 and myAirvo 2 devices.
Airvo 2 and myAirvo 2 devices are employed for administering high flow therapy to patients. It’s important to note that these devices are not intended for life support, and continuous patient monitoring is crucial. Any disruption to therapy could result in oxygen desaturation.
Fisher & Paykel Healthcare is coordinating with various international regulatory authorities to take appropriate action in each country. The company will also notify distributors, dealers, and hospitals that may have affected products and will replace any impacted devices. It’s estimated that approximately 9,000 of the affected devices are still in use.
Customers seeking information about the limited recall or requiring further assistance may contact their local Fisher & Paykel Healthcare representative, regional sales office, or distributor.
The company expects that the costs associated with this limited recall will be around $12 million, which will be accounted for in the financial statements for the year ending March 31, 2024. It’s worth noting that this recall was not anticipated or included in the updated financial guidance provided on March 22, 2024.
Furthermore, the company informs that the Taxation (Annual Rates for 2023-24, Multinational Tax, and Remedial Matters) Bill has passed its third reading in the New Zealand Parliament today.
This bill eliminates depreciation deductions for commercial and industrial buildings that were reinstated by the previous government. These changes are likely to affect the company’s tax expenses for the 2024 financial year. However, the company is currently unable to quantify the financial impact of these changes.