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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 ...
Recalled breathing assistance devices from Philips Respironics have been linked to 561 deaths, federal regulators said Wednesday. The death toll is an update to the U.S. Food and Drug ...
"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.
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 ...
On 16 August 2022, Philips announced that they had parted ways with van Houten due to a mass product recall of Philips Respironics CPAP devices that halved the company's stocks and would further reduce it below the value it had prior to his appointment as CEO.
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 ...