Philips, a medical device manufacturer, has announced a cessation of the sale of sleep apnea devices in the United States due to safety concerns that may elevate the risk of cancer, as part of a tentative agreement with federal regulators.
In 2021, the health technology company initiated a global recall of millions of breathing devices and ventilators over apprehensions regarding the foam used for noise and vibration reduction, which was suspected to pose health risks, including cancer.
As revealed in a quarterly earnings update on Monday, Philips has agreed to the conditions of a consent decree, which mandates a suspension of US sales until necessary improvements are implemented at its facilities.
The finalization of this agreement is contingent upon approval by a judge.
Sales Halt: Philips Commits to Servicing Recalled Devices
As per the terms of the agreement, Philips is committed to continuing the servicing of recalled machines in the United States, but the sale of new machines is temporarily suspended until the fulfillment of specified corrective actions mandated by the FDA.
To address the associated expenses required for compliance, the company has allocated a sum of $393 million, as disclosed by company executives.
Philips’ CEO, Roy Jakobs, assured analysts and investors that the company is dedicated to prioritizing “safety and quality” with an elevated level of accountability in all its endeavors.
The FDA’s official website cautions patients about potential risks associated with the ingestion of the sound-dampening foam, including headaches, asthma, allergic reactions, and more severe health issues.
In a November update, the FDA issued an additional warning, stating that the machines could, in rare cases, overheat, leading to the risk of fires.
The FDA has indicated its inability to comment on Philips’ announcement until a final agreement is “signed and filed with the court.”