Medical Device Safety Notice
Philips Respironics devices for sleep and respiratory therapy
FSN 2021-05-A & FSN 2021-06-A
In June 2021, Philips Respironics issued a voluntary Field Safety Notice (outside the US) following awareness of a potential health hazard associated with the foam used in certain CPAP, BiPAP and mechanical ventilators.
We recognize the significant impact of this Field Safety Notice on our patients, business customers and clinical teams. That's why we've developed tools and resources to help you through the proofreading process. These materials can be found on our patient, business partner and clinical team pages.
Our goal is to complete the repair and replacement program for the majority of registered patients by December 2022. We're making steady progress, always recognizing that things can't move fast enough for patients waiting for a repair or replacement device.
We post regular updates on our efforts through this website and monthly emails, including information about your replacement device(s).
Ozone cleaners, as well as UV light cleaning products, are not currently approved and must not be used as cleaning methods for sleep apnea devices and masks.
Continuous ventilator, minimal respiratory support, facility use