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# Philips Discussing Consent Decree Over Respironics Recalls
- URL: https://www.fdaweb.com/philips-discussing-consent-decree-over-respironics-recalls/
- Published: 2022-07-25T12:00:00.000Z
- Updated: 2026-09-14T17:53:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152351

Philips says it is undergoing discussions with the Department of Justice (DoJ) on behalf of FDA about the proposed terms of a consent decree involving the company’s troubled Respironics unit and its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. In late April, the company said it received a DoJ subpoena asking for information on the events that led to recent recalls of the devices ([see earlier story](https://www.fdaweb.com/justice-department-probe-on-philips-respironics-recall/)).

Operating under a consent decree is nothing new to the company. In 2017, Philips North America agreed to a consent decree with FDA that saw the company suspending external defibrillator manufacturing at its Andover, MA, and Bothell, WA facilities. The decree followed inspections in 2015 and earlier that documented GMP issues, according to the company. That same year, Phillips [recalled](http://fdaweb.com/login.php?sa=v&aid=D5138285&searchWords=phillips&cate=S&stid=%241%24F41.qX5.%24iToZz.UsJRwzX61DnJKSW%2F&ref=fdaweb.com) its HeartStart MRx Monitor/Defibrillator due to battery and electrical issues.

In 2020, [**FDA lifted**](https://www.usa.philips.com/healthcare/about/news/public-web-site-consent-decree?ref=fdaweb.com) certain provisions of the decree so that the company could [resume manufacturing and shipping external defibrillators for the U.S.](https://www.philips.com/a-w/about/news/archive/standard/news/press/2020/20200424-fda-lifts-injunction-on-manufacture-and-distribution-of-philips-defibrillators-in-the-us.html?%5Fgl=1%2A1n1225h%2A%5Fga%2ANjU0NzQwNjQ1LjE2NTg3NzE5Mjg.%2A%5Fga%5FQ243QQ1P76%2AMTY1ODc3NDMzMS4yLjAuMTY1ODc3NDMzMS4w%2A%5Ffplc%2AcXUzbEFrUjBQdUJxdnBFZ004M2J3dmlqemglMkIxOUdieVVSM0JsTlo3d1ZTMDRQYU5XcWVnSm5aS1FObEp2WjMzbnZNc2NxbHdSaVN1cmFXOHg2eFpGeWFwUTElMkJHRkxWb3RhJTJCVzlDaUxNaXlraTRybDllc25DSzV4WEJpVTFnJTNEJTNE&%5Fga=2.16124534.1740786473.1658771928-654740645.1658771928&ref=fdaweb.com) Philips continues to comply with other terms of the consent decree, which remains in effect, and includes ongoing regulatory compliance monitoring and FDA facility inspections.

News of the Justice Department’s new consent decree talks comes a few months after FDA issued a rare [Section 518(a)](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZH-2F-2BdT2Hfvce-2B9YoPQjyr3NbUdLzFfkAclTghtHjy3-2Bt7UGomlqrF-2BFUfe-2BO7kt7I-2FIQ0skxfLYWNV3TTrOX683mX7h-2FS99mS256-2BEQdNu2U9BXfQjOC-2FylbJPJ4m655Ufyx2TccpPbJwti-2FJwICMR4-3Dnr2F%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigCiXICIZPB4RGigCdTzpK2QgEtecQr07-2BqexlLIBD5kNw-2FavX-2BYh44pnfMa5xoVEfZ7c4fPTuxxLTO6Td0XyBUFDw0jqyBYL9AtNHmnJxERaTLj7pnnzkbgC4GWXLMPVWu3m2aR3zMnuyOCMPLjWQfaeuE-2BCI-2BCfREgc2ey8ZTGplX59tX-2BosOHyd7oXqzfeyxOCs-2BatljpQSp9PlbHqH6Ftg2e0q6psOM-2B-2BTgEbsWmBaeKAXN-2BcIMvdDZuNDfZgRbX2AFtVfvD0q-2FtlNZv2JYUk-2F-2BN2n9T6OPNcTV2cBcvU-3D&ref=fdaweb.com) notification order ([see story](https://www.fdaweb.com/philips-hit-with-rare-518-a-order-on-ventilators/)) to Philips Respironics requiring it to notify patients and others of the company’s 6/14/2021 recall of the ventilators, CPAP and BiPAP machines, and the “unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane sound abatement foam used in those products.” The [notification order](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZAmdierth9sDznGHUIlSHO9ei4TFsJLd8vCd6yy0SwYqCDyl3PlnVprxjkojIZPkAA-3D-3DdWuB%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigCiXICIZPB4RGigCdTzpK2QgEtecQr07-2BqexlLIBD5kNw-2FavX-2BYh44pnfMa5xoVEfZ7c4fPTuxxLTO6Td0XyBUFDw0jqyBYL9AtNHmnJxERaTLj7pnnzkbgC4GWXLMPVWu3m2aR3zMnuyOCMPLjWQffY5y-2FvyYGLXpqh-2BxoS5dZtWYvrxDkplKo4th2-2Fg4gIKlOB6vR0Iq55SnE7gjZ6E57uEFMVZnXrbp57sLNXoQzjGpD-2FgMJyMTApdypmOMIPkrQpzxJHY4HtE39hp0aMirozlHNkkQpMXIp-2FJ-2BqbED2A-3D&ref=fdaweb.com) was necessary due to what the agency described as “inadequate” company notification efforts to date.

“The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” CDRH director **Jeff Shuren** was quoted in a [release](https://www.fda.gov/news-events/press-announcements/fda-orders-philips-respironics-notify-patients-regarding-recall-certain-breathing-assistance?ref=fdaweb.com) as saying. “Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.”

FDA late last year inspected Philips Respironics and issued a [29-page Form FDA-483](https://www.fda.gov/media/154099/download?utm%5Fmedium=email&utm%5Fsource=govdelivery). The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ sound abatement foam ([see story](https://www.fdaweb.com/fda-hits-philips-with-29-page-483-over-recalled-device/)).