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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 ...
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.
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
A massive recall of Philips breathing devices in 2021 due to a risk of potential injury has left physicians scrambling to find alternatives for the growing number of people who use them. Philips ...
Philips Respironics's products include devices for the diagnosis and treatment of sleep apnea including CPAP and bi-level non-invasive ventilation machines, oxygen concentrators for patients requiring supplemental oxygen, infant apnea monitors for infants at risk of SIDS, asthma treatment solutions and hospital ventilators.
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 ...
In December, Philips said that its testing of one set of CPAP and BiPAP devices included in the recall found that the level of chemical emissions “is not typically anticipated to result in long ...
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