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.
The initial recall affected about 15 million breathing machines produced since 2006, though roughly five million were still in circulation in mid-2021.
With replacements not immediately available, the recall caused confusion and upset for many doctors and patients. Many struggled to weigh the risk of continuing to use a faulty device against the peril of sleeping with impaired breathing.
Millions of people suffer from sleep apnea, or interrupted breathing, which is associated with elevated rates of strokes, heart attacks and possible cognitive decline. Recalled machines included CPAP, or continuous positive airway pressure, machines; BiPap devices; and ventilators.