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 know the profound impact this recall has had on our patients, business customers, and clinicians. We're committed to patient safety, and partnering with clinicians and customers to ensure we're doing all we can to help patients. More information on the recall can be found via the links below.
Based on the extensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices.
** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. Philips Respironics’ guidance for healthcare providers and patients remains unchanged. Philips Respironics will continue with the remediation program.
(Emergency Use Authorization)
Also known as DreamStation BiPAP autoSV
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
In-Lab Titration Device
Also known as BiPAP Hybrid A30Ventilator (A-Series)
(not marketed in US)
Also known as BiPAP V30 Auto Ventilator (A-Series)
Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)
Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)
If your device is affected...
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.
Disclaimers * Voluntary recall notification in the US/field safety notice for the rest of the world.
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