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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 Respironics received and continues to receive device associated complaints that have subsequently been filed as medical device reports with the U.S. health regulator," the company said.
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 ...
Philips said in a statement it had flagged the matter with the FDA itself after a review Philips conducted over the past three months that found 270 complaints over the over the past three years.
It said complaints about the foam were limited and were evaluated on a case-by-case basis, and it was made aware of the significance in early 2021, launching the recall soon after. Months after the recall, Philips said that tests showed the chemicals released by the foam were within safe levels. [2]
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 ...
After Respironics was sold to Philips in 2008, McGinnis stepped down from his leadership role. [1] When Respironics recalled its machines in 2021 due to a defect which caused noise-reducing foam to degrade and release toxic chemicals, McGinnis attributed the recall to a culture shift in the company following the Philips' takeover, calling it a ...
"for "With Every Breath," a series exposing the scope of a corporate cover-up that allowed Philips Respironics to continue marketing breathing machines around the globe years after the FDA received warnings about contaminants in the machines and the company's own experts concluded that the devices posed severe health risks to users"