Millions of Defective Sleep Apnea Machines Recalled By Firm

The American government has ordered Philips, maker of sleep apnea equipment recalled worldwide, to stop making them until they satisfy safety standards.

A U.S. Department of Justice court order mandates firm reform of production and quality control systems and independent expert review of proposed improvements. All consumers in the United States who have faulty devices must also continue to get replacements, repairs, or refunds from the corporation.

The most often mentioned equipment is machines that use continuous positive airway pressure (CPAP) to maintain an open airway in the nose and mouth while the patient sleeps. If sleep apnea is not addressed, it can result in serious sleepiness and an increased risk of heart attack.

Since 2021, Philips has recalled approximately 5 million of these devices due to a potential health risk associated with the gradual breakdown of the interior foam. This might allow users to breathe in small particles and odors while they sleep. Prolonged delays in repairing or replacing the equipment have irritated U.S. authorities and patients.

The legal agreement requires independent auditors to help Philips determine how to address the sleep devices’ manufacturing issues and how to monitor them. The proposal must receive a final green light from the FDA before proceeding. The specialists must also attest that the newly chosen foam satisfies FDA safety requirements.

Over seven years of using a Philips machine, they caused Jeffrey Reed and more than seventy-five others to suffer from chronic sinus infections and two episodes of pneumonia. As a result, over seventy-five others have sued Philips for bodily harm related to these devices. Australia, Chile, Israel, and Canada now host similar litigation.

In 2022, the FDA unusually ordered Philips to increase consumer outreach regarding the recall, including providing “clearer information about the health risks of its products.” According to the agency’s estimates, about half of Americans who had recalled machines were unaware of the recall.

Customers who have attempted to get their money back or replacement or reconditioned equipment from the business have complained of lengthy wait times.