A federal court has ordered Philips RS North America LLC (Philips Respironics) to stop manufacturing many of its sleep and respiratory devices at three Pennsylvania facilities, until certain requirements are met.
The U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips Respironics, Respironics California LLC, and Philips Holding USA Inc., and Roy Jakobs, CEO of Royal Philips, along with several other individual defendants.
The consent decree, with limited exceptions, restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. after the company’s adulterated and misbranded sleep devices were recalled.
The medical supply company owned by Philips has been ordered to stop distributing such devices until it takes specific measures designed to increase the safety of its devices and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).
In a complaint filed in the Pennsylvania court, the Department of Justice on behalf of the FDA alleged that Philips Respironics, a subsidiary of Philips Holding USA Inc., violated the FDCA by manufacturing and distributing adulterated and misbranded medical devices.
Philips Respironics had recalled certain ventilators, CPAP and BiPAP machines in June 2021 because of potential health risks—impacting 15 million devices worldwide.
Immediately following the recall, the FDA issued an alert notifying device users that problems reportedly associated with the PE-PUR foam breakdown could potentially result in serious injury.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said this marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.
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