We know that you are eager to find out when you’ll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. We understand the profound impact this recall has had on you, and that for those who are waiting for a repaired or replaced device, this progress can’t come quickly enough.
One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. We are partnering with clinicians and business customers throughout this process to ensure we’re doing all we can to help you and your healthcare needs.
We will continue to provide regular updates to you through monthly emails.
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.
February 13, 2023
Click here to learn moreDecember 14, 2022
Click here to learn more(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.
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