RELATED PRESS / 2022
Jeffrey Reed, who suffered persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device at his home in Marysville, Ohio. Philips, the company that is recalling sleep apnea devices worldwide, announced that it would stop selling the devices in the United States, as part of a tentative agreement with regulators that could cost the company about $400 million.
WASHINGTON (AP) — The company that recalls sleep apnea devices worldwide said Monday it will block the sale of the devices in the U. S. as part of a tentative deal with regulators that could cost the maker about $400 million.
Device maker Philips has recalled more than five million pressurized breathing machines due to the threat of their internal foam degrading over time, leading users to inhale small debris while sleeping.
The company first announced this in mid-2021, but efforts to repair or upgrade the machines have dragged on for years, frustrating patients in the U. S. and other countries.
The Dutch company said it has agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The deal has not yet been finalized and will have to be approved by a U.S. judge. Philips executives disclosed the tentative agreement during a quarterly earnings update.
Under the terms of the agreement, Philips would continue to service the recalled machines in the U. S. It would not sell new machines until it has complied with several corrective measures set by the FDA. Company executives said they have set aside $393 million to cover expenses needed to comply.
The company pledged to put “safety and quality at the heart of everything we do with a greater degree of responsibility,” Philips CEO Roy Jakobs told analysts and investors.
The FDA’s website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions and more serious problems. In November, the agency issued a new warning that the machines can overheat, in rare cases causing fires.
The company said it would not comment on Philips’ announcement until a final agreement has been “signed and filed in court. “
In 2022, the FDA took the rare step of directing Philips to intensify its visitor contact efforts in connection with the recall, adding “clearer data about the health hazards of its products. “At the time, the company estimated that only a portion of other people in the U. S. were able to find a solution to the problem. U. S. companies that had affected machines knew they had been recalled.
Customers trying to obtain refunds or new or refurbished devices from the company have reported months of delays.
The machines are called continuous positive airway tension (CPAP) machines, and they force air through a mask to keep the passages open during sleep.
Untreated sleep apnea can prevent other people from breathing many times a night, leading to harmful sleepiness and an increased risk of heart attack. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults. affected.
The latest announcement does not include the 675 personal injury lawsuits filed against the company over the devices. Those lawsuits were consolidated in federal court in Pennsylvania.
Philips faces lawsuits in Canada, Australia, Israel and Chile, according to the company’s update.
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