Maker of defective sleep apnea devices ordered to overhaul manufacturing
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
Six killed in a 'foiled coup' in Congo, the army says
KINSHASA, Congo (AP) — Six people were killed and dozens arrested following attacks on the residence2024-05-21- Before Monday's solar eclipse happens, eagle eyed skygazers will have a once-in-a-lifetime opportuni2024-05-21
How to tell if you have the sleep disorder that even doctors don't know about
Do you struggle to get out of bed without an alarm clock, then feel tired all day?You might assume t2024-05-21Sydney Police searching for an officer over disappearance of two men
Luke Davies, left, and Jesse Baird. Photo: Supplied/Instagram2024-05-21Burglar hurled stolen mobile phones at police from the top of 60ft high roof during nine
A burglar hurled stolen mobile phones at police officers from the top of a roof during a nine-hour s2024-05-21From House Sparrows to Blue Tits: The stunning birds spotted the most often in UK gardens
Sparrows, blue tits and starlings top the list of birds spotted in UK gardens this year –but some on2024-05-21
atest comment