This agreement, if approved by a U.S. judge, could cost the manufacturing giant nearly $400 million.

The recall was initiated due to concerns that the internal foam of over 5 million pressurized breathing machines could degrade over time, exposing users to inhale tiny particles and fumes while they sleep. Although the issue was first disclosed in mid-2021, the process of repairing or replacing the affected machines has faced significant delays, leading to frustration among patients in the U.S. and other countries.

As part of the consent decree with the Food and Drug Administration (FDA) and the Department of Justice, Philips will continue to service previously sold machines in the U.S., but will not be able to sell new devices until it fulfills the corrective actions outlined by the FDA. To meet these requirements, the company has allocated $393 million for operational changes and necessary upgrades.

The FDA has warned patients about the potential risks of ingesting the sound-dampening foam, which may include headaches, asthma, allergic reactions, and more serious health problems. In a rare move, the FDA ordered Philips to improve its communication with customers about the recall in 2022, as many affected individuals were unaware of the issue. The agency estimated that only about half of the people in the U.S. with affected machines were aware of the recall.

Customers seeking refunds or replacement devices have reported significant delays in obtaining them from Philips. The majority of the recalled devices are continuous positive airway pressure (CPAP) machines that help keep airways open during sleep. Additionally, certain lines of ventilators and other breathing devices have also been recalled by the company.

Sleep apnea, when left untreated, can lead to frequent pauses in breathing during sleep, causing drowsiness and increasing the risk of heart attacks. It affects a considerable proportion of adults, with estimates ranging from 10% to 30%, predominantly affecting men.

Regarding the potential harm caused by inhaling foam particles from the machines, Philips has referred to studies commissioned by the company, suggesting that the harm to patients is unlikely to be significant. The company has already discontinued several of the recalled models.

It is important to note that this announcement does not resolve the 675 personal injury lawsuits filed against Philips concerning these devices. These cases have been consolidated in a federal court in Pennsylvania.

As of now, the FDA has refrained from commenting on Philips' announcement, stating that they can only provide further input once a final agreement is "signed and filed with the court." The approval of the tentative agreement and subsequent actions taken by Philips will determine the resolution of this ongoing issue.