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Philips, maker of millions of recalled sleep apnea machines, agrees to halt U.S. sales
The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer nearly $400 million.
Device maker Philips has recalled more than 5 million pressurized breathing devices due to risks that their internal foam can break down over time, leading users to inhale tiny particles while they sleep.
The company first announced the problem in mid-2021, but efforts to repair or replace 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.
$393 million set aside
Under terms of the agreement, Philips would continue servicing recalled machines in the U.S., but would not be able to sell new ones until meeting several corrective actions laid out by the FDA. Company executives said they have set aside $393 million to deal with expenses needed to comply.
The company promised it would put “safety and quality at the center of everything we do with a greater level of accountability,” 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 agency said it cannot comment on Philips’ announcement until a final agreement is “signed and filed with the court.”
Customer delays
In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including “clearer information about the health risks of its products.” At the time, the agency estimated only about half the people in the U.S. with 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 devices are called continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep passageways open during sleep.
Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.
The latest announcement does not resolve 675 personal injury lawsuits filed against the company over the devices. Those suits have been consolidated in a federal court in Pennsylvania.
Philips faces similar legal action in Canada, Australia, Israel and Chile, according to the company’s update.
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U.S. troops leaving Niger bases this weekend and in August after coup, officials say
The U.S. will remove all its forces and equipment from a small base in Niger this weekend and fewer than 500 remaining troops will leave a critical drone base in the West African country in August, ahead of a Sept. 15 deadline set in an agreement with the new ruling junta, the American commander there said Friday.
Air Force Maj. Gen. Kenneth Ekman said in an interview that a number of small teams of 10-20 U.S. troops, including special operations forces, have moved to other countries in West Africa. But the bulk of the forces will go, at least initially, to Europe.
Niger’s ouster of American troops following a coup last year has broad ramifications for the U.S. because it is forcing troops to abandon the critical drone base that was used for counterterrorism missions in the Sahel.
Ekman and other U.S. military leaders have said other West African nations want to work with the U.S. and may be open to an expanded American presence. He did not detail the locations, but other U.S. officials have pointed to the Ivory Coast and Ghana as examples.
Ekman, who serves as the director for strategy at U.S. Africa Command, is leading the U.S. military withdrawal from the small base at the airport in Niger’s capital of Niamey and from the larger counterterrorism base in the city of Agadez. He said there will be a ceremony Sunday marking the completed pullout from the airport base, then those final 100 troops and the last C-17 transport aircraft will depart.
Speaking to reporters from The Associated Press and Reuters from the U.S. embassy in Niamey, Ekman said that while portable buildings and vehicles that are no longer useful will be left behind, a lot of larger equipment will be pulled out. For example, he said 18 4,000-pound (1,800-kilograms) generators worth more than $1 million each will be taken out of Agadez.
Unlike the withdrawal from Afghanistan, he said the U.S. is not destroying equipment or facilities as it leaves.
“Our goal in the execution is, leave things in as good a state as possible,” he said. “If we went out and left it a wreck or we went out spitefully, or if we destroyed things as we went, we’d be foreclosing options” for future security relations.
Niger’s ruling junta ordered U.S. forces out of the country in the wake of last July’s ouster of the country’s democratically elected president by mutinous soldiers. French forces had also been asked to leave as the junta turned to the Russian mercenary group Wagner for security assistance.
Washington officially designated the military takeover as a coup in October, triggering U.S. laws restricting the military support and aid.