The U.S. District Court for the Western District of Pennsylvania restricted Philips Respironics from producing and selling new respiratory devices from several facilities in the U.S., the FDA said April 9.
In 2021, the devicemaker recalled about 3.5 million ventilators and continuous positive airway pressure and bi-level positive airway pressure machines in the U.S. — and 15 million worldwide — because a foam used to reduce sound and vibrations could break down and be inhaled.
The agency flagged additional issues in the reworked devices more than a year after the initial recall, and Philips pulled more than 13,000 reworked devices from the market in early 2023. Violations of good manufacturing practices were later observed at Philips sites in Pennsylvania and California, the FDA said.
Subsidiaries of Philips, Philips Holding USA and Philips Respironics, agreed with the Justice Department and FDA's consent decree. The company also agreed with the recall remediation plan, which outlines a time frame for progressive corrections related to its devices.
"Strengthening patient safety and quality remains Philips' highest priority and the increased scrutiny will help us to improve even more," company CEO Roy Jakobs said in a news release. "With the agreement on a consent decree for Philips Respironics in place, we now have a clear path forward to gradually restore the business, serving patients around the world."
More than 99% of registered CPAP and BiPAP devices have been remediated across the world, Philips said. Remediation of recalled ventilators is ongoing, according to the release.