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# Philips Respironics, FDA Reach Consent Decree
- URL: https://www.fdaweb.com/philips-respironics-fda-reach-consent-decree/
- Published: 2024-01-29T12:00:00.000Z
- Updated: 2026-09-14T14:21:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156231

Philips Respironics says it has reached agreement with FDA on the terms of a consent decree over the company’s struggles to resolve issues surrounding its troubled ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. “Until the relevant requirements of the consent decree are met, Philips Respironics will not sell new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the U.S.,” a [company release](https://www.philips.com/a-w/about/news/archive/corpcomms/news/press/2024/philips-fourth-quarter-results-2023.html?ref=fdaweb.com) says.

Philips Respironics says the consent decree is being finalized and will be submitted to a U.S. court for approval. “The decree will provide Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business,” it says. Although it is stopping sales in the U.S. of affected devices, the company says it will “continue to service sleep and respiratory care devices already with healthcare providers and patients, and supply accessories (including patient interfaces), consumables (including patient circuits), and replacement parts (including repair kits).”

In 2022, Phillips Respironics reported it was undergoing discussions ([see story](http://fdaweb.com/login.php?sa=v&aid=D5152351&cate=&stid=%241%24lq1.K84.%24Xx%2FX4hX1lcdqQ7uFYlAc31&ref=fdaweb.com)) with the Department of Justice (DoJ) on behalf of FDA about the proposed terms of the consent decree. The company also said it received a DoJ subpoena asking for information on the events that led to recent recalls of the devices ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5151684&searchWords=respironics&cate=S&stid=%241%245c..oQ%2F.%24Hcc60b7uPhal9hNABbKQq0&ref=fdaweb.com)).

Last year, Royal Philips and its U.S. subsidiaries, including Philips Respironics, had allocated $615 million under an agreement to resolve all “economic loss claims” in the U.S. Multidistrict Litigation (MDL) related to Respironics’ [voluntary recall](https://www.usa.philips.com/healthcare/e/sleep/communications/src-update?ref=fdaweb.com) of certain sleep and respiratory care devices ([see story](https://fdaweb.com/login.php?sa=v&aid=D5155268&cate=&stid=%241%245R2.oh0.%24.fzULwa2myhkb9tPC.%2FPs%2F&ref=fdaweb.com)).

The just-completed consent decree has also led Phillips Respironics to record a provision for associated costs of almost $400 million in the fourth quarter of 2023\. The company says it also expects additional charges in 2024 related to remediation activities and disgorgement payments for Philips Respironics sales in the U.S.

FDA has declined to comment until the agreement is approved by the court.