A French investigating magistrate has been looking into whether Dutch medical device maker Philips committed aggravated fraud in relation to faulty sleep apnoea machines, sources told AFP on Monday.
In 2021, Philips launched a recall of DreamStation machines for sleep apnoea, a disorder in which breathing intermittently stops during sleep.
Millions of devices were recalled over concerns that users were at risk of inhaling or swallowing pieces of toxic sound-absorbing foam and fears it could potentially cause cancer.
The Paris prosecutor’s office confirmed to AFP it has received 104 complaints from individuals, two from associations as well an alert from France’s medical device regulator in connection with the devices which were used by several hundred thousand French patients.
Several were complaints of involuntary homicide in relation to the devices.
The prosecutor’s office said an investigation was opened in June into possible fraud and whether the company met its obligations to report incidents that could cause the death of a patient.
The probe follows a preliminary investigation opened in 2023 that collected evidence and analysed documents.
Following additional testing Philips said the devices posed no health risks, but it agreed in 2024 to pay $1.1 billion to settle US lawsuits related to the machines, although it acknowledged no liability.
Philips told AFP that probe concerns its actions during the 2021 recall of the machines and that it does not concern the quality of its current machines.
