Safety Notice for Medical Devices

Philips Respironics Devices for Sleep and Respiratory Therapy  

FSN 2021-05-A & FSN 2021-06-A

After becoming aware of a potential health risk associated with the foam in certain CPAP, BiPAP, and mechanical ventilator devices, Philips Respironics issued a voluntary safety notice (outside the USA) in June 2021.

We are aware of the significant impact this safety notice has on our patients, business customers, and clinical teams. Therefore, we have developed tools and resources to support you during the correction process. You can find these materials on our pages for patients, business partners, and clinical teams.

Our goal is to complete the repair and replacement program for the majority of registered patients by December 2022. We are making steady progress and are always aware that for patients waiting for a repair or replacement device, it cannot go fast enough. 

We regularly publish updates on our efforts through this website and monthly emails, including information about your replacement device(s).

Ozone cleaners as well as cleaning products with UV light are currently not approved as cleaning methods for sleep apnea devices and masks and must not be used.