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In June 2021, the FDA first announced the recall of Philips Respironics BiPAP and CPAP devices—which are worn overnight while someone sleeps—as well as ventilators, saying the polyester-based ...
Earlier this week, Philips said it would not sell new devices to treat sleep apnea in the U.S. in the coming years as it works to comply with a settlement with the FDA.Philips said it had reached ...
A 2021 recall of Philips breathing devices is related to 561 deaths, the U.S. Food and Drug Administration said Wednesday. 561 deaths linked to recalled Philips sleep apnea machines, FDA says Skip ...
The Amsterdam-based healthcare technology company has been grappling with the fallout of a global recall in June 2021 of millions of respirators used to treat sleep apnea over worries that foam ...
Respironics is an American medical supply company owned by Philips that specializes in products that improve respiratory functions. It is based in the Pittsburgh suburb of Murrysville in Pennsylvania, United States. Some of its products had hazardous foam that disintegrated and entered patients' bodies.
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.
AMSTERDAM (Reuters) -Philips shares surged 35% early on Monday as the medical devices maker announced a smaller-than-expected settlement to resolve claims over recalled breathing devices in the ...