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. |
China remains popular destination for foreign investment: FM spokespersonChicago Cubs second baseman Nico Hoerner misses 4th straight game with left hamstring issueJudge says South Carolina can enforce 6China remains popular destination for foreign investment: FM spokespersonChina, Azerbaijan vow to lift bilateral relations to new heightsNew Hampshire Senate tables bill inspired by state hospital shootingCroatia gets new government with a farXi, Putin jointly meet pressGolfer's prompt release from jail rankles some who recall city's police turmoilThitikul shoots 65 for 2