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
Independent UN experts urge Yemen’s Houthis to free detained Baha'i followers
CAIRO (AP) — Human rights experts working for the United Nations on Monday urged Yemen’s Houthi rebe2024-05-212 killed when a small plane headed to South Carolina crashes in Virginia, police say
Two people were killed when a small plane headed for South Carolina crashed in Virginia, authorities2024-05-21155 police officers injured at German soccer match, most from tear
BERLIN (AP) — Some 155 police officers were injured in fighting involving Dynamo Berlin and Energie2024-05-21The yearly memorial march at the former death camp at Auschwitz overshadowed by the Israel
OSWIECIM, Poland (AP) — U.S. university presidents joined Holocaust survivors and thousands of Israe2024-05-21What a blast to work at NASA. Space agency is sky
WASHINGTON (AP) — Exploring the cosmos makes for happy employees, federal workers like to work from2024-05-21Money isn't enough to smooth the path for Republican candidates hoping to retake the Senate
WASHINGTON (AP) — Frustrated by the seemingly endless cash flowing to Democrats, Republicans aiming2024-05-21
atest comment