Voluntary Recall Information
Philips Respironics Sleep and Respiratory Care devices
In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). We are focused on delivering the best care possible, while supporting patients, customers and clinicians throughout the remediation process.
Approximately 2,840,000 new devices and repair kits produced to meet the U.S. registration demand*
Approximately 2,490,000 devices remediated and in the hands of U.S. patients and Durable Medical Equipment providers (DMEs)**
Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.
Latest updates
A conversation with David Ferguson, Business Leader, Sleep and Respiratory Care
David Ferguson, Business Leader, Sleep & Respiratory Care, joined Philips in March 2021. Since then, he has led the organization through the voluntary medical device recall of certain CPAP, BiPAP and Mechanical Ventilator devices. With the comprehensive test and research program for affected CPAP/BiPAP sleep therapy devices† now complete, we asked him about what’s changed since the start of the recall, what the test results mean for patients, and what to expect from Philips Respironics in the future.
† First-generation DreamStation, System One and DreamStation Go devices
July 2023 latest results and conclusions for sleep therapy devices related to the impact of ozone cleaning shows no appreciable harm to health in patients
Philips Respironics completed the analyses for System One and DreamStation Go sleep therapy devices indicating that the volatile organic compounds (VOCs) and the particulate matter (PM) emissions related to foam degradation are within the appliable safety limits. Additional visual assessments have been performed and confirm the low prevalence of significant foam degradation.
Resolution of US economic loss litigation reached
Philips has reached an agreement, subject to Court approval, to resolve all economic loss claims brought by private plaintiffs in the United States related to the Philips Respironics voluntary recall of certain sleep and respiratory care devices.
Patients, hospitals and sleep labs eligible for benefits under the agreement do not need to take any action at this time in order to participate in the proposed settlement. The settlement must be approved by the Court, and additional information will be provided to you in the future.
All related inquiries should be directed to the third-party Settlement Administrator, Angeion Group. For more information, please visit www.RespironicsCPAP-ELSettlement.com or call 855-912-3432.
* As of August 31, 2023 ** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Repair kits are utilized in the rework process to create a recertified unit. To learn more, click here.
