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Last week, the U.S. Food and Drug Administration (FDA) announced that previously recalled sleep apnea machines have now been tied to the deaths of over 550 people. In June 2021, the FDA first ...
The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer ...
The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could ...
The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a long-awaited ...
McGinnis developed the "Nasal CPAP Mask System," a continuous positive airway pressure (CPAP) machine for the treatment of sleep apnea, [3] based on the original 1981 design by Dr. Colin Sullivan. [4] After receiving FDA approval in 1984, Respironics began selling the first commercially available CPAP machine a year later. [5]
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 ...