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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 ...
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 ...
AMSTERDAM (Reuters) -The U.S. Food and Drug Administration (FDA) said it is still not satisfied with how Dutch healthcare technology company Philips has handled a major product recall and the ...
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.
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.
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.
A massive recall of Philips breathing devices in 2021 due to a risk of potential injury has left physicians scrambling to find alternatives for the growing number of people who use them. Philips ...
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