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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 ...
"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 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.
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 ...
After selling the company, McGinnis founded another medical device company called Respironics in 1976. In the early 1980s, the company developed a CPAP machine called the SleepEasy, receiving FDA approval in 1984. The machines were a commercial success and helped establish Respironics as a major player in the medical device industry. [3]
In June 2021, Philips announced a voluntary recall of several of its Respironics ventilators, BiPAP, and CPAP machines due to potential health risks. Gradual degradation of foam in the devices, intended to reduce noise and vibrations during operation, could result in patients inhaling particulates or certain chemicals. [157]
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