The Magazine for Sleep Professionals
Friday, April 24, 2026
Royal Philips today provides an update on the comprehensive test and research program of its subsidiary Philips Respironics to assess potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific sleep therapy and ventilator devices under the voluntary June 2021 recall notification/field safety notice.* The risk […]
Program update As we approach the end of 2022, we expect to complete around 90% of the production this year for the delivery of replacement devices to patients. Patients who are still waiting to receive their replacement device can expect to continue hearing from us as we work through some […]
Testing in accordance with ISO 18562 and ISO 10993 standards conducted by five certified, independent testing laboratories in the US and Europe This update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results to date. Philips will continue to provide regular updates as new […]
In June 2021, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices. At the time the […]
The FDA’s Center for Devices and Radiological Health is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices […]
The following email was sent to users on February 3, 2022. We’re writing to you with two important updates about your recalled Philips device.* As always, thank you for your continued patience as we work hard to ensure as many patients as possible can continue safely with their therapy. Our […]
SoClean Inc. has filed a federal lawsuit in the United States District Court for the District of Massachusetts against Philips. According to the complaint, Philips has misled the public and engaged in acts of deliberate misdirection, placing blame on SoClean to divert attention away from obvious design flaws, including a poor choice […]
The email below was sent to Philips’ CPAP users on October 15, 2022 We are pleased to share an important update regarding your Philips device replacement. Philips received authorization from the US Food and Drug Administration (FDA) for the repair and replacement program for devices impacted by the June 14, […]
