Philips CPAP Recall

A federal court recently ordered Philips Respironics to stop making and selling specific sleep therapy machines until it can prove it meets particular compliance requirements. The court further mandated a recall remediation plan in the consent decree so all affected patients could receive new devices, refurbished machines, or partial refunds related to a 2021 recall due to health risks from Philips sleep apnea machines.

Jeff Shuren, M.D., J.D., Director of the Food and Drug Administration’s Center for Devices and Radiological Health, stated, “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.” Dr. Shuren stated that this action marks the first time a medical device company has provided a remediation payment option for a recalled device under a consent decree.

The Philips CPAP Machine

In 2021, Philips recalled 15 million devices, and since then, the company has failed to consistently deliver quality CPAP and BiPAP machines. Specifically, sound abatement foam inside the machines degraded with use. As a result, users inhaled or swallowed small pieces of black foam and associated chemicals due to PE-PUR degradation. According to the FDA, users suffered severe injuries and even death. Affected users are still filing lawsuits against the company, seeking compensation for their injuries related to defective CPAP machines.

Department of Justice Lawsuit

The United States Department of Justice (DOJ) filed suit against Philips Respironics, alleging the company sold medical devices that didn’t meet quality standards, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). In its complaint, the DOJ alleged that the Philips devices were misbranded because the company failed to report machine modifications per FDA requirements. The complaint further stated that additional violations of acceptable manufacturing practices were observed at Philips Respironics’ Mt. Pleasant, Pennsylvania, facility in 2023 and during numerous inspections of the company’s subsidiary facility in Carlsbad, California, which has now ceased manufacturing operations.

The Recall Remediation Plan

The Philips mandated recall remediation plan, which requires the company to take specific actions to address issues with the recalled devices. The Philips plan includes remediation options and communication requirements:

• Remediation Options – Philips must offer patients new or refurbished devices of the same or equivalent model, including a renewed warranty. Patients may also elect to receive a refund for specific models.
• Communication Requirements – Philips must make multiple attempts to contact medical equipment providers and affected users. Patients must register the device’s serial number, select a remediation option, and provide prescription information.

Contact Silent Night Therapy

At Silent Night Therapy, we encounter patients who have struggled with sleep for years and are left feeling hopeless or confused about their sleep issues. We offer diagnostic options to help people receive the correct diagnosis of sleep apnea or other sleep-related health issues to reach the solution and results they deserve. Contact us online or at 631-983-2463 to get started.