FDA update April 11, 2024

Federal District Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

A federal district court entered a consent decree against Philips Respironics (Philips). The consent decree includes key provisions aimed to prioritize patient relief and ensure the company’s regulatory compliance. The consent decree comes after Philips recalled certain ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pressure (BiPAP) machines in June 2021 because of potential health risks—impacting 15 million devices worldwide. Patients impacted by the Philips recall remain a top priority for the agency as the Food and Drug Administration (FDA) continues to take steps to protect the health and safety of individuals using these devices.

The consent decree includes provisions:

• Requiring implementation of a Recall Remediation Plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall by way of receiving a new or reworked/remediated device, or for certain devices, providing the option for a partial refund.
• Restricting, with limited exceptions, the production and sale of new CPAP machines, BiPAP machines, and other devices at several Philips Respironics facilities in Pennsylvania and California until certain requirements are met.

“The finalization of this decree is a significant milestone. Throughout this recall, we have provided patients with important health information, by issuing numerous safety communications, and have taken actions rarely used by the agency to help protect those impacted by this recall,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”

For more information on this update, email mdi at:
[email protected] and RE: Respironics.