Medical Device Safety Notice
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.
The products listed below are affected by the Field Safety Notice:
CPAP and BiLevel PAP machines
All affected devices manufactured before April 26, 2021, all device serial numbers
Continuous ventilator, minimal respiratory support, facility use
Which products are not affected and why?
Products not affected may contain other soundproofing foams as new materials and technologies become available over time. Additionally, due to the design of the device, the soundproofing foam may be located in a different location on non-affected devices.
- Trilogy Evo
- M series
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- A-Series Pro and EFL
- Dream Station 2
- Omnilab (Original based on Harmony 2)
- Dorma 100, Dorma 200, & REMStar SE
- V60 ventilator
- V60 Plus ventilator
- V680 ventilator
All oxygen concentrators, respiratory therapeutics delivery products, respiratory clearing products.