"Philips Halts US Sales of Recalled Sleep Apnea Machines Amid FDA Deal"

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Source: The Associated Press
"Philips Halts US Sales of Recalled Sleep Apnea Machines Amid FDA Deal"
Photo: The Associated Press
TL;DR Summary

Philips, the company behind a global recall of sleep apnea machines, has agreed to stop selling the devices in the U.S. under a tentative agreement with regulators, potentially costing the manufacturer nearly $400 million. The recall, affecting over 5 million pressurized breathing machines, was due to risks of their internal foam breaking down over time, leading users to inhale tiny particles and fumes while they sleep. Philips has agreed to a consent decree with the FDA and the Department of Justice, and while it will continue servicing previously sold machines, it cannot sell new ones until it meets corrective actions laid out by the FDA. The company faces personal injury lawsuits and legal challenges in multiple countries over the devices.

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