(Reuters) -France has not opened a new investigation into the recall of Philips’ sleep apnea devices, a spokesperson for the company said on Monday in response to local media reports of a new criminal proceeding.

A 2021 recall affected about 15 million devices 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.

“Ongoing proceedings launched in 2023 cover the alleged activities of Philips in the lead up to and during the 2021 recall,” a spokesperson for the Dutch healthcare technology told Reuters in an emailed statement.

“The proceeding does not make allegations about the quality and safety of products currently marketed in France by Philip

See Full Page