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The new issue identified by the FDA involves the heating element in a humidifier used in the "DreamStation 2" sleep therapy device. Philips said in a statement it had flagged the matter with the ...
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 ...
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 ...
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 ...
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.
Months after the recall, Philips said that tests showed the chemicals released by the foam were within safe levels. [2] The company announced a new CPAP machine in April 2021, and soon after admitted that the foam it had used previously had been breaking down in an earnings call.
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]
Philips recalls ventilators, sleep apnea machines due to health risks. Toby Sterling. June 14, 2021 at 5:52 AM. ... Around two-thirds of Philips CPAP machine sales are in the United States.