Maker of defective sleep apnea devices ordered to overhaul manufacturing
Time:2024-05-01 08:08:56 Source:worldViews(143)
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.
You may also like
- WADA defends pick of Swiss prosecutor under scrutiny in review of Chinese swimmers case
- World Asia Esports Championship scheduled for September in China
- Guangdong sink Beijing in OT, end losing skid
- Palace Museum 'meets' Palace of Versailles
- Denise Welch confirms she's moved house after knife
- Marinos see off Shandong to seal first ACL semis
- Demonstration zone in Hainan shows China's green practices
- The Civil War raged and fortune
- Nigerians struggle with fuel shortages as queues form across major cities