THE Therapeutic Goods Administration (TGA) has commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements.
These included devices used in the home for sleep apnoea and breathing difficulties.
The devices contained a polyester-based polyurethane (PE-PUR) foam used for noise suppression, which risked degrading and potentially being inhaled or ingested by patients.
The TGA alleges that the devices supplied from 2 Jun 2019 to 13 Oct 2022 were unsafe, did not perform as intended, and were therefore unlawfully supplied.
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