The Australian regulator TGA is suing Philips Australia for safety issues with sleep apnea devices. These problems came to light four years ago. Philips already reached a settlement after an American lawsuit regarding the sleep apnea devices.
Philips imported devices between June 2019 and October 2022 that do not meet Australian safety requirements, according to TGA. The devices help people with apnea breathe better during sleep. However, the insulation foam in the machines could detach and potentially be inhaled. This could cause a lack of oxygen.
The TGA reports that Philips unlawfully supplied more than 44,000 devices during the period mentioned. The US previously took the manufacturer to court.
The company reached a settlement of 1.1 billion dollars (then over 1 billion euros) with the American watchdog to avoid lawsuits. In addition, Philips has entered into an agreement to financially compensate American patients.
In response to the news, Philips emphasizes that the current charge says nothing about the quality and safety of products that the company now sells in Australia. The Eindhoven-based concern says it will study the TGA statement and cooperate constructively with the judicial procedures.