Philips faces French criminal investigation over sleep apnea recall

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By Gianluca Lo Nostro

(Reuters) – Paris prosecutors opened a criminal probe into Philips in June over its recall of sleep apnea devices, probing possible charges including aggravated fraud and failure to report safety incidents that could cause death, they said on Monday.

The 2021 recall affected about 15 million machines worldwide, including 350,000 in France, after concerns emerged that degrading polyurethane foam could cause health problems ranging from headaches and respiratory irritation to potential cancer risks.

The Paris Public Health division confirmed on Monday that it had received 104 individual complaints, prosecutors said in an emailed statement to Reuters.

The judicial investigation was formally opened on June 12 after a preliminary inquiry by the Central Office for the Fight against Environmental and Public Health Damage (OCLAESP).

In response, a Philips spokesperson said this is not a new investigation.

“Ongoing proceedings launched in 2023 cover the alleged activities of Philips in the lead up to and during 2021 recall. The proceeding does not make allegations about the quality and safety of products currently marketed in France by Philips.”

The company will continue to engage constructively in the required court processes, the spokesperson told Reuters.

The fraud charges in the Philips case carry severe criminal penalties under French law. For aggravated fraud involving endangering human health, individuals face up to seven years’ imprisonment and fines of 750,000 euros, while corporations can be fined up to 3.75 million euros, prosecutors said.

Last year, Philips agreed to pay $1.1 billion (937.5 million euros) to settle related litigation in the United States.

Philips shares were down 1% by 1400 GMT after they fell nearly 5% following reports of a new French criminal probe.

(Reporting by Gianluca Lo Nostro and Jakob van Calster; Editing by Matt Scuffham)