Italy orders Philips to fast-track recall of sleep apnea devices

An Italian court has ordered Dutch multinational Philips to replace defective sleep apnea breathing devices by April 30, according to a ruling viewed Friday by AFP.

The court in Milan ordered the embattled company facing a massive worldwide recall to accelerate its replacement of the faulty machines that should have been completed by December 31, according to the March 30 decision.

Two consumer associations in Italy had sued Philips on behalf of the 100,000 Italian users of the machines for sleep apnea, a disorder in which breathing stops and starts during sleep.

Some 55,000 people in Italy are still waiting for a replacement from Philips, the groups say.

The company faces a fine of 20,000 euros ($21,800) per day if the replacements are not completed by April 30, the court ruled.

A lawyer for the plaintiffs, Stefano Bertone, told Il Corriere della Sera newspaper they had shown "that Philips was fully aware of the problem at least since 2014, but waited until after 2021 to intervene".

Philips said in a statement that it was considering its next steps to take, which could include filing an appeal.

"A dedicated team is working very hard to get a resolution to patients as fast as possible," Philips said, calling it a "complex undertaking" because of the number of devices to be replaced and the efforts to contact each user.

The company added that it had ramped up capacity for replacement devices.

The worldwide recall of the company's breathing devices, begun in 2021, contributed to Philip's loss of 1.6 billion euros last year, and it said in January that it would cut another 6,000 jobs on top of an earlier announced cut of 4,000 positions.

The company faces ongoing investigations and lawsuits in the United States as well.

In announcing the recall in 2021, Philips said sound-dampening foam in the machines could degrade, causing people to inhale or swallow pieces of the foam with "possible toxic and carcinogenic effects".

In its statement Friday, Philips said results from tests to better understand health risks showed that the "prevalence of visible foam degradation is low" in its first-generation "DreamStation" devices.

The emission of particulates, it said, was "not expected to result in appreciable harm to health in patients".

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© Agence France-Presse