Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines | FDA
Patients impacted by the Philips recall remain a top priority for the agency as the FDA continues to take steps to protect the health and safety of individuals using these devices.
Explained: Philips Respironics consent decree
In this case, the consent decree is with the FDA and meant to address FDA’s concerns around certain quality-related matters, in part following from an FDA inspection of a Respironics’ manufacturing …
Talking Sleep | The Philips consent decree and the path forward
May 17, 2024 · It states that Philips Respironics cannot manufacture or distribute new sleep and respiratory care devices in the U.S. market until certain criteria are met, unless the devices are …
Philips Agrees to FDA Consent Decree Over Respiratory Device Recall
Jan 29, 2024 · Philips has reached an agreement with the US Department of Justice, representing the US Food and Drug Administration, on the terms of a consent decree focused on Philips Respironics …
Philips Respironics Consent Decree Update - CPAP-Supply.com
Apr 11, 2024 · On April 9, 2024, the consent decree agreed to by Philips Respironics and the US Department of Justice (DOJ), representing the US Food and Drug Administration (FDA) went into effect.
FDA Announces Federal Court Enters Consent Decree Against Philips ...
Apr 9, 2024 · Immediately following Philips' recall, the FDA issued an alert notifying device users that problems reportedly associated with the PE-PUR foam breakdown could potentially result in serious …
Philips’ Perspective on Its Consent Decree with the DOJ | Sleep Review
Apr 10, 2024 · Philips will prioritize completing the remediation of sleep and respiratory care devices under a voluntary recall. It will also ensure ongoing compliance with FDA regulations and continue …
Federal Court Enters Consent Decree Against Philips Respironics ...
The federal court entered a consent decree of permanent injunction against Philips Respironics following a recall of certain sleep therapy machines manufactured by the company.
Philips stops selling sleep, respiratory devices in US due to FDA ...
Jan 29, 2024 · Philips has agreed to stop selling new sleep therapy devices or other respiratory care products in the U.S., roughly two-and-a-half years after launching its massive recall of related …
Philips Respironics agrees on consent decree | Philips
Apr 10, 2024 · Further to communicating main consent decree terms on Jan. 29, 2024, Philips Holding USA and Philips Respironics have reached final agreement with DOJ and FDA.