Philips Recall of Bi-Level PAP and CPAP Devices

Philips Respironics—a company related to Royal Philips of Germany—began a voluntary recall issued in June 2021 of over 3.5 million Philips Respironics CPAP and BIPAP machines.

The recall was for the following devices manufactured before April 26, 2021:

  • E30
  • DreamStation ASV
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go
  • Dorma 400
  • Dorma 500
  • REMstar SE Auto


Bi-Level PAP and CPAP Recall Cause

The recall was announced because of problems with the polyester-based polyurethane used as a noise-reducing foam in Philips Continuous and Non-Continuous Ventilators, which include BIPAP and CPAP units. The polyester-based polyurethane foam, sometimes referred to as “PE-PUR,” may degrade into particles that could then be inhaled or ingested by the user and/or may release certain gases which can also be inhaled by the user. Additionally, unapproved cleaning methods, such as the use of ozone cleaners, may accelerate the foam’s degradation.

The defects now being found with the PE-PUR foam may result in serious injury which could be permanent and even life-threatening. Philips Respironics has received several complaints regarding the presence of black debris found in the air path of the units which is caused by the PE-PUR foam. Users of the devices have also reported experiencing headaches, airway irritation, chest pressure, and sinus, and other infections. An inflammatory response to the exposure of the degrading PE-PUR foam can result in irritation to the skin, eye, and respiratory tract, headache, asthma, and adverse effects potentially including toxic carcinogenic effects. Thankfully, though, as of the time of writing, there has been no report of death caused by these issues.


Philips Respironics is recommending that all users of these devices undertake these immediate actions:

  1. Discontinue the use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue the use of your device due to a lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks
  2. Register your device on the recall website.
  3. The website provides you current information on the status of the Bi-level PAP and CPAP recall and how to receive permanent corrective action to address the two (2) issues.
  4. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
  5. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.

Philips Respironics reports that it is taking steps for corrective action to the devices. No concrete information has yet been revealed, as of July 2021. If you have suffered injuries attributable to these recalled Philips Respironics BIPAP and CPAP products, please call Foley & Small.


Affected by the CPAP Recall? – Foley & Small Can Help

Foley & Small is undertaking the handling of cases involving these recalled Philips Respironics products. Foley & Small has years of experience handling mass tort litigation cases in a variety of contexts, including claims involving other defective medical implants and defective drug products. Please call Foley & Small or complete the new client inquiry form on the Foley & Small website. Foley & Small strives to treat all of its clients as members of the family, providing care for our clients as we would for members of our families in dealing with injuries suffered from defective medical devices.

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