FDA Approves Consent Decree Addressing Philips Respironics CPAP and BiPAP Recall

The U.S. District Court for the Western District of Pennsylvania has approved a consent decree of permanent injunction against Philips Respironics and associated entities, along with individual defendants, including the CEO of Royal Philips. This decree restricts the production and sale of new CPAP and BiPAP machines at certain Philips Respironics facilities in the U.S. until specific requirements are met. These requirements stem from a June 2021 recall due to potential health risks posed by deteriorating foam in certain devices. The consent decree mandates a Recall Remediation Plan, overseen by the FDA, which includes options for device remediation, such as replacement or refund. Notably, this marks the first time a device company offers a remediation payment option under a consent decree. Key provisions of the decree include export restrictions, independent testing of replacement foam, and ensuring regulatory compliance across all Philips Respironics facilities. The FDA remains committed to prioritizing patient safety and facilitating the efficient implementation of the Recall Remediation Plan.

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Source: https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep