Fisher & Paykel Healthcare has issued a voluntary limited recall for batches of its Airvo 2 and myAirvo 2 devices, which were manufactured before August 14 2017.
The recall is due to a speaker configuration issue that may cause distorted, intermittent, or inaudible alarm sound levels.
Approximately 9,000 of the affected devices are still in use.
The company is working with international regulatory authorities and will be contacting distributors, dealers, and hospitals to replace the affected devices.
The estimated cost of the recall is $12 million, which was not included in the company's previous financial guidance.
In a separate announcement, Fisher & Paykel Healthcare said the recently passed Taxation Bill in New Zealand may impact its tax expense for the 2024 financial year, but the financial impact has not been quantified yet.
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