The action is a major step toward resolving one of the biggest medical device recalls in history, which has dragged on for nearly three years.will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a
Philips has recalled more than 5 million of the machines since 2021 because their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep. Efforts to repair or replace the machines have been plagued by delays that have frustrated regulators and patients in the U.S. and other countries.
Under the legal agreement, Philips must hire independent auditors to create a plan for fixing its manufacturing problems and for monitoring problems with the sleep devices. The plan must then be approved by the Food and Drug Administration. The experts must also certify that new foam selected by the company meets FDA safety standards.
Reed received a newer Philips device after returning his old machine, but he doesn't like to use it, preferring a competitor's device.Reed is one of more than 750 people who have filed personal injury lawsuits against the company over the devices. Those cases have been consolidated in a federal court in Pennsylvania.The Dutch manufacturer announced in January it had reached a tentative agreement with the FDA and the Department of Justice. But U.S.
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