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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 ...
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 ...
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.
Only in 2021 did Philips recall the machines, which had been delivered across the United States and many other countries. Over 3,700 complaints across more than 11 years were held back from the FDA, which device makers are required to do so within 30 days of reports of patient injuries in addition to investigating them.
That year the U.S. Food and Drug Administration received thousands of consumer complaints that the foam components in CPAPs, BiPAPS, and ventilators sold in the U.S. under the Philips Respironics ...
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 ...
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Old logo (1972-2018) The United States Consumer Product Safety Commission (USCPSC, CPSC, or commission) is an independent agency of the United States government.The CPSC seeks to promote the safety of consumer products by addressing "unreasonable risks" of injury (through coordinating recalls, evaluating products that are the subject of consumer complaints or industry reports, etc ...