Philips Respironics announced on Monday that it would halt sales of all of its breathing machines in the United States after reaching a settlement with the Food and Drug Administration over continuing 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 bits 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 “multiyear” plan before it could resume business in the United States. The company said further details would be disclosed when the agreement was finalized in court. But it added that it would continue to repair existing devices and provide service for people using them.
The company initially began the recall of millions of devices in June 2021 and paused sales of new sleep therapy machines to the United States, according to Steve Klink, a spokesman for Philips. At the time, the company and the F.D.A. cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.
The company has since released results of additional testing, saying the devices were “not expected to result in appreciable harm to health in patients,” and it said it was continuing to conduct tests. The F.D.A. has pushed back on some of the company’s updated claims, and at one point called them “unpersuasive.” Philips has also faced continuing scrutiny and undertaken more recalls in its attempts to upgrade the devices.
Dr. Jeff Shuren, director of the F.D.A.’s device division, said the agency could not comment until the agreement was finalized and filed with the court.