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:
Pennsylvania Senate approves GOP's $3B taxHow England's new singleJoe Collier, former Bills head coach, dies at 91Harvey Weinstein back at Rikers Island after hospital stayBig Ten women's basketball schedule brings USC, UCLA to conference's easternmost schoolsDoja Cat proudly shows off the results of her breast reduction and liposuction in a seeMet Gala 2024: Doja Cat boldly dons massive wet TWeddings should be subsidised by the government for lowMother of Australian surfers killed in Mexico gives moving tribute to sonsBig Ten women's basketball schedule brings USC, UCLA to conference's easternmost schools
2.9564s , 4667.1328125 kb
Copyright © 2024 Powered by Maker of defective sleep apnea devices ordered to overhaul manufacturing ,World Winds news portal