Dive Brief:
- The Paris Prosecutor’s Office confirmed with MedTech Dive that it has opened an investigation into Philips over its recalled sleep apnea and respiratory devices.
- Philips faces charges including aggravated fraud related to goods that pose a danger to human health and failure to report incidents that could lead to death or serious deterioration of health, a spokesperson for the prosecutor’s office wrote in an email. Reuters first reported the investigation.
- Philips recalled more than 15 million sleep apnea devices and ventilators in 2021 due to the risk of users inhaling particles from toxic soundproofing foam, which the Food and Drug Administration said at the time could cause inflammation, asthma, and “toxic carcinogenic effects.” Philips is still resolving proceedings related to the recall, including an investigation by the U.S. Department of Justice, the company said in its second-quarter earnings report.
Dive Insight:
The Paris public prosecutor’s office began a preliminary investigation into the Philips recall in 2022. A Philips spokesperson wrote in an email that the latest investigation is not new, adding that the proceeding “does not make allegations about the quality and safety of products currently marketed in France by Philips.”
The aggravated fraud charge brought by the prosecutor’s office carries a fine of 750,000 euros for individuals and 3.75 million euros for legal entities, the Paris prosecutor’s spokesperson wrote. They added the prosecutor’s public health division has received 104 complaints from people to date.
In the U.S., Philips agreed to a $1.1 billion settlement last year related to personal injury lawsuits and a class action settlement for medical monitoring. The settlements were fully paid in the first half of 2025, Philips said in its latest earnings report.
In June, Philips said Australia’s Therapeutic Goods Administration began enforcement proceedings for alleged violations of the country’s Therapeutic Goods Act related to the recall. Philips said it could not estimate whether there would be any financial impact.
