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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 ...
Philips (PHG) is recalling some Bi-Level PAP, CPAP, and mechanical ventilator devices in the United States due to health risks. Philips (PHG) Recalls CPAP, Ventilators Used for Sleep Apnea Skip to ...
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.
The medical technology and equipment giant Philips has recalled some of its ventilators and CPAP machines due to a form piece that could potentially become toxic and cause cancer in its users.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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"Philips has received reports of possible patient impact due to foam degradation," the company said in a statement. "To date, there have been no reports of death as a result of these issues."