US Says Philips Lacks Recall Information | Financial

The American regulator, the FDA, warns against this, which has ordered the Dutch company to inform all patients, suppliers and doctors affected by the devices in question of the technical problems. Philips recalled millions of sleep apnea devices last year because the insulating foam can crumble, posing health risks.

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The FDA recognizes the frustration of patients and medical device suppliers who were unaware of the recall and who were not provided with sufficient information about the next steps in the recall process,” said Jeff Shuren, Director of the FDA Medical Devices Division on the Supervisor’s website.

Philips began its recall of some 5.2 million devices worldwide in June 2021. The regulator says it previously warned the tech company that information about the dangers of sleep apnea devices had not reached everyone. world.

In its own press release, Philips claims to have reached “the vast majority” of users or providers of sleep apnea devices in the United States in two sets of information. Around 2.6 million devices are now registered. Philips also sends alerts through the mobile app for patients with sleep apnea.

The FDA has previously criticized Philips for the recall of sleep apnea devices. The American Food and Consumer Product Safety Authority wrote last fall that Philips should have known much sooner that there were issues with the products, but failed to investigate further after the complaints were reported. .

Philips has set aside 725 million euros for the recall. There may also be claims for damages.