As for the United States, Philips has not received any information about the recall

Philips, a medical technology company in the United States, has failed to inform clients about the withdrawal of certain devices for sleep apnea patients. The U.S. regulator, the FDA, warns against this, ordering the Dutch company to notify all patients, suppliers and physicians concerned with the equipment in question regarding technical issues. Phillips recalled millions of sleep breathing devices last year because the insulating foam would shatter and be detrimental to health.

“The FDA is noticing frustration among patients and medical device suppliers who are unaware of the recall and has not received enough information about the next steps in the withdrawal process,” said Jeff Shuren, director of the FDA’s medical device division. Regulatory website.

Philips began recalling about 5.2 million devices worldwide in June 2021. The regulator says it has warned the technology company in advance that information about the dangers of sleep apnea devices has not reached everyone.

In its own statement, Philips claims to have reached “the vast majority” of users or suppliers of breathing apparatus in two sleep rounds in the United States. About 2.6 million devices are now registered. Philips also sends alerts via mobile app to patients with sleep apnea.

The FDA has previously sued Phillips over the recall of sleep apnea devices. The U.S. Food and Consumer Product Safety Commission wrote last fall that Philips should have known in advance that there were issues with the products, but failed to investigate further after the complaints were reported.

Philips has booked அழைக்க 725 million for the recall. There may also be claims for damages.