On June 2, 2025, the Therapeutic Goods Administration (TGA), Australia’s medical device regulatory agency, started proceedings in the Federal Court of Australia against Philips for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements.

These included devices used by people with sleep apnea at home and other devices used by patients who need help breathing.

The devices, recalled in 2021, contained a polyester-based polyurethane foam used for noise suppression, due to a risk of the foam degrading and then particulates being inhaled or ingested by the patient.

In addition, for the Trilogy 100, Philips supplied devices with a silicone foam as a replacement. There was a real risk of the silicone foam dislodging from its position and blocking the air pathway. This could stop the device from working, resulting in ventilation failure or underventilation. This could then result in hypoventilation, hypoxemia, hypercapnia, and asphyxia.

The Therapeutic Goods Administration alleges that, due to the risk of the polyester-based polyurethane foam degrading and silicone foam dislodging, the devices supplied from June 2, 2019 to October 13, 2022 (depending on the device) were unsafe, did not perform as intended, and were therefore unlawfully supplied. It alleges there were over 44,000 separate instances of unlawful supply of devices in that period.

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