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The new issue identified by the FDA involves the heating element in a humidifier used in the "DreamStation 2" sleep therapy device. Philips said in a statement it had flagged the matter with the ...
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
Jun. 15—Medical equipment company Philips has issued a recall on some products to address possible health risks associated with a foam component meant to help reduce noise. The polyester-based ...
Earlier this year, Dutch medical device maker Royal Philips reached a $1.1 billion deal to settle thousands of claims stemming from a recall in 2021 of millions of its breathing machines like ...
During the pandemic, Philips conducted a series of studies on the foam, showing the deteriorating foam and chemicals released by it, which could cause "serious injury, life-threatening or permanent impairment". [2] The company said patients' health is its top priority, and regretted the "distress and concern" that the recall caused.
"Philips’ first priority is the health and well-being of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care ...
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