The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S.
The settlement comes nearly three years after the company acknowledged that an industrial foam fitted inside its machines ...
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 ...
Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines ...
Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep ...
A U.S. federal court has officially ordered Philips to restrict the production and sale of its CPAP and BiPAP ventilators for sleep apnea. The move is the culmination of a years-long international ...
Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.
Philips (NYSE:PHG) on Wednesday reported that it has reached a final agreement with the U.S. Justice Department and Food and Drug Administration on a consent decree related to its Respironics ...
Philips announced the main terms of an agreement it reached in January with the U.S. government on its new sleep apnea ...
SILVER SPRING, Md., April 9, 2024 /PRNewswire/ -- Today, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North ...
Decree Includes Key Provisions Aimed to Prioritize Patient Relief and Ensure Company's Regulatory Compliance SILVER SPRING, Md., April 9, 2024 /PRNewswire/ -- Today, the U.S. District Court for ...