Philips suspends sales of ventilators in the US after a recall

Philips Respironics announced Monday that it would stop sales of all its ventilators 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 they blew chunks of foam and potentially toxic gases into consumers' airways.

Under the settlement, Philips said it would have to meet a list of standards in a “multi-year plan” before it could resume operations in the United States. The company said further details would be announced when the deal was finalized in court. But it added that it would continue to repair existing devices and provide service to people who use them.

The company initially began recalling millions of devices in June 2021 and halted sales of new sleep therapy machines to the United States, said Steve Klink, a spokesman for Philips. At the time, the company and the FDA raised the possibility of serious injury or permanent damage from the potentially cancer-causing chemicals emitted by the devices.

The company has since released the results of additional testing, saying the devices were “not expected to cause appreciable harm to patient health,” and said it was continuing to conduct tests. The FDA has pushed back on some of the company's updated claims, at one point calling them “unpersuasive.” Philips has also faced continued scrutiny and issued more recalls in its efforts to upgrade the devices.

Dr. Jeff Shuren, director of the FDA's device division, said the agency could not comment until the agreement was finalized and filed in court.

The first recall affected about 15 million ventilators produced since 2006, although about five million were still in circulation as of mid-2021.

Because replacements were not immediately available, the recall caused confusion and upset among many doctors and patients. Many struggled to weigh the risk of continuing to use a defective device against the danger of sleeping with impaired breathing.

Millions of people suffer from sleep apnea, or interrupted breathing, which is associated with increased rates of strokes, heart attacks and possible cognitive decline. Recalled machines included CPAP machines, or continuous positive airway pressure machines; BiPap devices; and fans.

Philips, based in Amsterdam, announced that it had reached an agreement, or consent decree, reached with the US Department of Justice and the FDA, along with the release of its fourth quarter results. The company said it has recorded approximately 363 million euros in connection with the costs of completing the settlement requirements. The stock, which trades in the United States, fell about 7 percent Monday morning.

The company said it would continue to sell its products in other countries.

Thousands of patients have since sued Philips, claiming the machines led to a wide range of respiratory and other ailments, including allegations of deaths from lung cancer. In September, the company reached a $479 million settlement with the plaintiffs, intended to cover financial losses associated with repairing or replacing the machines. Lawsuits over illnesses and medical costs are still ongoing.