Under a long-awaited settlement announced Tuesday by federal officials, the company responsible for a worldwide recall of sleep apnaea machines will be barred from resuming production at U.S. facilities until it meets safety requirements.
Philips will be required to hire independent experts for vetting the changes to its manufacturing and quality control, the Justice Department announced in a court order.
The Justice Department also required the company to replace, repair, or refund all defective devices purchased by U.S. consumers, the department said.
They also required the Food and Drug Administration to approve the new changes.
This recall has dragged for nearly three years, and it affects mostly continuous positive airway pressure, or CPAP, machines. These machines work by forcing air through a mask to keep the mouth and the nasal passageways open during sleep. Sleep apnea causes people to stop breathing during sleep temporarily, and the condition can lead to heart disease dangerous drowsiness if left untreated.
Philips has already recalled more than 5 million such machines since 2021. The defective machines’ internal foam can wear down and be inhaled by users.
The company has delayed its attempts to repair and replace the machines, much to the frustration of regulators and patients.
Efforts to repair or replace the machines have been plagued by delays that have frustrated regulators and patients in the U.S. and other countries.
“This office, the FDA and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk,” U.S. Attorney Eric Olshan said in a statement.
The Associated Press contributed to this article.