Philips Respironics announced Monday that it will stop selling all of its breathing machines in the United States after reaching a settlement with the Food and Drug Administration over ongoing problems with the devices.
Millions of the company’s ventilators and CPAP machines, used to ease breathing at night, were recalled after reports that they blew foam and potentially toxic gases into consumers’ airways.
Under the agreement, Philips said it must meet a list of standards in a “multi-year” plan before it can resume business in the United States. The company said further details would be disclosed once the settlement is finalized in court. But it also said it would continue to repair existing equipment and provide service to people who use them.
According to Philips spokesperson Steve Klink, the company initially began recalling millions of devices in June 2021 and halted sales of new sleep therapy machines in the United States. At the time, the company and the FDA cited the potential for serious injury or permanent harm from potentially cancer-causing chemicals released from the devices.
The company has since released additional testing results, saying the devices are “not expected to cause any notable harm to patients’ health” and said it is continuing to conduct testing. The FDA has rejected some of the company’s updated claims, at one point calling them “unexpected.” Philips has also faced continued scrutiny and more recalls in its efforts to upgrade devices.
Dr. Jeff Shuren, director of the FDA’s device division, said the agency could not comment until the agreement was finalized and filed with the court.
The initial recall affected approximately 15 million breathing machines produced since 2006, although about five million were still in circulation in mid-2021.
With replacements not immediately available, the recall caused confusion and distress for many doctors and patients. Many people struggled to weigh the risk of continuing to use the faulty device against the risk of sleeping with bad breath.
Millions of people suffer from sleep apnea, or interrupted breathing, which is linked to higher rates of stroke, heart attacks and possible cognitive decline. The recalled machines included CPAP, or continuous positive airway pressure, machines; BiPap device; And ventilator.
Philips, which is based in Amsterdam, disclosed with its fourth-quarter earnings announcement that it had reached a settlement, or consent decree, with the U.S. Department of Justice and the FDA. The company said it had written off approximately $363 million euros related to the costs of meeting settlement requirements. Its stock, which trades in the United States, was down about 7 percent on Monday morning.
The company said it will continue to sell its products in other countries.
Thousands of patients have since sued Philips, claiming the machines caused a wide range of respiratory and other illnesses, including lung cancer deaths. In September, the company reached a $479 million settlement with plaintiffs, intended to cover financial losses related to repairing or replacing the machines. The lawsuit over illnesses and medical costs is still pending.