The manufacturer responsible for a worldwide recall of sleep apnea machines announced on Monday that they will discontinue sales of the devices in the United States. This decision was made as part of a tentative agreement with regulators and could result in a loss of nearly $400 million for the company.
Philips, the manufacturer of devices, has issued a recall for over 5 million pressurized breathing devices. The reason for the recall is the potential breakdown of internal foam over time, which could result in users inhaling small particles during sleep.
The issue was initially disclosed by the company in the middle of 2021, but the process of fixing or exchanging the machines has been delayed for several years, causing frustration among patients in the United States and other nations.
The Netherlands-based corporation announced that it has reached a settlement with the Food and Drug Administration and the Department of Justice. The terms of the agreement are still being worked out and must be authorized by a judge in the United States. Philips leaders revealed the preliminary deal during a quarterly financial report.
$393 million set aside
According to the terms of the contract, Philips will still provide maintenance for machines that have been recalled in the United States. However, they will not be permitted to sell new machines until they fulfill various corrective measures mandated by the FDA. The company’s leaders have announced that they have allocated $393 million to cover the costs of meeting these requirements.
The CEO of Philips, Roy Jakobs, assured analysts and investors that the company would prioritize safety and quality and increase accountability in all aspects of their operations.
The FDA’s online platform cautions individuals about potential dangers associated with consuming the sound-absorbing material, such as headaches, asthma, allergies, and potentially more severe complications. In November, the agency released a fresh advisory stating that the equipment may experience overheating, which could lead to fires in rare instances.
The agency stated that it is unable to provide a comment on Philips’ declaration until a final agreement has been “executed and submitted to the court.”
In 2022, the FDA made the uncommon decision to require Philips to increase its communication with customers regarding the recall, specifically providing more comprehensible details about the potential health hazards of its products. At the time, the agency estimated that only half of the individuals in the United States who owned affected machines were aware of the recall.
Customers have experienced delays for months when attempting to receive refunds or new/refurbished devices from the company.
CPAP machines, short for continuous positive airway pressure, are devices that deliver air through a mask to maintain open airways while sleeping.
Sleep apnea that is not treated can result in individuals experiencing hundreds of occurrences where they stop breathing during the night, which can lead to hazardous fatigue and an elevated likelihood of having a heart attack. This issue is more prevalent in men compared to women, with approximations indicating that 10% to 30% of adults are affected.
The most recent update does not settle 675 legal cases regarding personal injuries that have been filed against the company for their devices. These cases have been combined and are now being heard in a federal court in Pennsylvania.
According to the latest update from the company, Philips is also facing legal action in Canada, Australia, Israel, and Chile.