WASHINGTON (AP) — 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 settlement announced Tuesday by federal officials.
Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or provide refunds to all U.S. customers who got the defective devices, the department said.
The action is a major step toward resolving one of the biggest medical device recalls in history, which has dragged on for nearly three years.
Most of the devices recalled are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep mouth and nasal passageways open during sleep. Left untreated, sleep apnea can lead to dangerous drowsiness and increased risk of heart attack.
Related articles:
Related suggestion:
Shen Meets ACWF's Executive Committee Members, Specially Invited Delegates from Hong Kong, MacaoSupporting Women As They Play Greater Roles in Scientific, Technological InnovationShen Yueyue Stresses Promoting HighACWF and UN Women Working Hand in Hand, Supporting Women in Coping with COVIDACWF Holds Gathering to Celebrate CPC CentenaryShen Yueyue Calls for Women's Contributions to a Successful Beijing 2022Shen Attends SCO Forum on PeopleNine unforgettable moments from the Hangzhou Asian Para GamesACWF Extends Festival Greetings to Women Athletes, Workers and Volunteers in Paralympic VillageState Councilor Stresses Stable Employment, Supporting Women's Entrepreneurship
3.1673s , 6498.125 kb
Copyright © 2024 Powered by Maker of defective sleep apnea devices ordered to overhaul manufacturing ,Culture Circle news portal