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 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.
cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.
Persons:
Philips Respironics, Philips, Steve Klink
Organizations:
Food and Drug Administration, Philips
Locations:
United States