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:
Flexen and DeJong help the White Sox beat the Rays 4Kevin McCloud builds his very OWN Grand Designs: TV star, 64, transforms 400Coach Malone reminds the Nuggets they're the defending champs and asks them to play like itGiants place outfielder Jorge Soler on the 10Urologist convicted of patient sex abuse, including of minorsIvey signs bill putting response deadlines in state's weak open records lawCoach Malone reminds the Nuggets they're the defending champs and asks them to play like itMariners send starting pitcher Hancock to TripleMontgomery throws 7 solid innings and Diamondbacks hold off Reds 4Pennsylvania will make the animal sedative xylazine a controlled substance
2.6634s , 6498.9765625 kb
Copyright © 2024 Powered by Maker of defective sleep apnea devices ordered to overhaul manufacturing ,Culture Currents news portal