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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 ...
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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.
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 ...
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.
The Dutch medical devices maker started the process on March 29 and has recalled 73,000 devices in the United Sates. Philips was recalling the ventilators after detecting contaminants such as dust ...
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