The settlement comes nearly three years after the company acknowledged that an industrial foam fitted inside its machines ...
A U.S. federal court has officially ordered Philips to restrict the production and sale of its CPAP and BiPAP ventilators for ...
Philips (NYSE: PHG) today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ).
Philips announced the main terms of an agreement it reached in January with the U.S. government on its new sleep apnea ...
Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy 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 ...
Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep ...
Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.
In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including "clearer information about the health risks of its products." At the time ...
Under the consent decree, Philips (PHG) Respironics will continue to prioritize completing the remediation of the sleep and respiratory care devices under its voluntary 2021 recall. Philips (PHG ...
and Philips Holding USA Inc., and Roy Jakobs, CEO of Royal Philips, along with several other individual defendants named in the decree. The consent decree, with limited exceptions, restricts the ...