Written By : Michelle Llamas
Edited By : Sophia Clifton
This page features 2 Cited Research Articles

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Why Did Philips Recall Their CPAP Machines?

Philips CPAP machines were recalled because polyester-based polyurethane (PE-PUR) used to control sound and vibration in some CPAP, BiPAP and ventilator machines may break down and release toxic particles and gasses that users may inhale or swallow.

The FDA classified the Philips CPAP recall as a Class I recall in July 2021. Class I recalls are the most serious type of recall for products that may lead to death or serious injury.

Philips said people CPAP device users could inhale or ingest foam particles or gases that may cause toxic, carcinogenic and respiratory effects. Foam degradation may be worse in machines used in hot or humid conditions or if people use ozone cleaners, the company said.

Side Effects Associated with Recalled CPAP Devices

CPAP side effects associated with recalled devices stem from ingesting or inhaling toxic particles include: Cancer, chemical exposure risk, respiratory issues and other toxic effects.

Potential side effects linked to recalled Philips CPAP devices include:
  • Asthma and other breathing problems
  • Toxic chemical poisoning
  • Hypersensitivity reactions
  • Lung and pulmonary disease and damage
  • Organ damage such as liver problems or kidney problems
  • Respiratory failure
  • Throat, nose and ear inflammation
  • Various cancers, including but not limited to: Bladder, breast, kidney, prostate, lung and liver cancer

Side effects of recalled CPAP machines have led some people to file Philips CPAP lawsuits. In studies and lawsuits, cancers linked to PE-PUR foam exposure include: Lung cancer, bladder cancer and stomach cancer.

People who filed lawsuits are also claiming new or worsening breathing problems such as asthma, organ injury and inflammatory conditions of the ear, nose and throat, among other health problems.

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Which CPAP Machines Were Recalled?

Most of the recalled CPAP machines are from the first generation Philips DreamStation line. The recall doesn’t affect the DreamStation2, which according to Philips contains foam that doesn’t have the same problems.

Devices manufactured between 2009 and April 26, 2021 are all included in the recall. According to Philips, more than half of the recalled devices were sold in the U.S.

Recalled Philips CPAP and BiPAP device brands include:
  • C-Series ASV
  • C-Series S/T and AVAPS
  • Dorma 400
  • Dorma 500
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • E30 (Emergency Use Authorization)
  • Noncontinuous Ventilator
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne (Q-Series)
  • SystemOne ASV4
Recalled Philips ventilator brands include:
  • A-Series BiPAP A30
  • A-Series BiPAP A40
  • A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
  • A-Series BiPAP V30 Auto
  • Garbin Plus, Aeris, LifeVent
  • Trilogy 100
  • Trilogy 200

The Philips CPAP recall also includes some of their ventilators. Recalled models include: Trilogy 100 and 200 ventilators and other models not marketed in the U.S.

How to Check if Your CPAP Was Recalled

If you aren’t sure if your Philips CPAP machine is included in the recall, you can check the Philips website to see pictures of recalled machines. You can also use the website to look up serial numbers and read instructions on how to register your device with Philips.

Consumers who don’t have internet access can call 1-877-907-7508 for help with registering their device. The page also has information for physicians and medical care providers.

What to Do If Your Philips CPAP Machine Was Recalled

If your CPAP or BiPAP machine has been recalled, Philips recommends discontinuing use of the device and speaking to your medical providers about treatment options. Your doctor may allow you to stop CPAP treatment if your sleep apnea is mild.

In some cases, your doctor may determine that the benefits of continuing to use your recalled device outweigh the health risks.

If you have decided to speak to a lawyer, you should do so right away because there is a time limit to file a lawsuit. Before you send your machine back to Philips, decide if you want to file a lawsuit. Lawyers urge consumers who want to file a lawsuit to keep their old machines for evidence and contact them right away.

Replacing a Recalled CPAP

Philips offers a repair and replacement program for affected devices. Patients, users or caregivers can look up the serial number of their device and begin a claim.

The company has said it will replace the PE-PUR sound abatement foam in affected CPAP devices with new foam that doesn’t have the same problems. Consumers who want to join Philips’ repair and replace program can sign up on the Philips website.

You may also want to speak to your doctor about CPAP alternatives. These include lifestyle changes, implants or surgery that may improve symptoms of sleep apnea.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: November 17, 2021

2 Cited Research Articles

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  1. Philips. (n.d.). Medical Device Recall Notification. Retrieved from https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
  2. U.S. Food and Drug Administration. (2021, September 10). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks