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. These materials can be found 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 happen quickly 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.
The following products are affected by the safety notice:
CPAP and BiLevel PAP Devices
All affected devices manufactured before the 26th.
April 2021 manufactured, all device serial numbers
Continuous ventilator, minimal respiratory support, use by a facility
Products that are not affected may contain other sound-absorbing foams, as new materials and technologies become available over time.Additionally, the soundproofing foam in unaffected devices may be positioned differently due to the device's construction.
Trilogy Evo
M-Series
Trilogy Evo OBM
Trilogy EV300
Trilogy 202
A-Series Pro and EFL
DreamStation 2
Omnilab (Original based on Harmony 2)
Dorma 100, Dorma 200, & REMStar SE
V60 Ventilator
V60 Plus Ventilator
V680 Ventilator
All oxygen concentrators, products for the administration of respiratory therapeutics, products for airway clearance.
