Risk of injuries related to breathing polyester-based polyurethane (PE-PUR) foam include:

The recalled Philips CPAP and ventilator devices have been linked to an increased risk of airway contamination, chemical exposure, and possible cancer.

  • Lung Cancer
  • Throat Cancer
  • Stomach Cancer
  • Intestinal cancer
  • Liver Cancer
  • Kidney Cancer
  • Other Organ Cancers
  • Liver Injury/Failure
  • Kidney Injury/Failure
  • Other Organ Total Failure/Injury/Organ Damage
  • Significant respiratory distress leading to secondary injury, primarily heart attack
  • Sudden onset total respiratory failure
  • Chemical burns on the lungs
  • Asthma (onset after start of use of the CPAP)
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On June 14, 2021, Dutch medical equipment company Philips announced that it would be recalling over 3,400,000 sleep apnea machines, also known as Continuous Positive Airway Pressure (CPAP) machines and ventilators sold before April 2021.  The recalled units are made with a foam part that may degrade and produce a toxic gas that potentially causes cancer.  The recall only affects units sold in the United States.

The U.S. Food and Drug Administration noted that the purpose of the recall was to “mitigate potential health risks related to the sound abatement foam component” of the devices. 

The recall announcement issued in June 2021 is a follow-up to a previous notification from April 2021.

This recall notification comes more than a month after Philips noted a “quality issue” involving CPAP machines and ventilators while publicizing the company’s first-quarter 2021 sales results, and after the release of the DreamStation 2 model which has a completely different sound abatement foam component.

Why is Phillips Recalling these Units?

The recalled Philips CPAP and ventilator devices have been linked to an increased risk of airway contamination, chemical exposure, and possible cancer. The problem is related to polyester-based polyurethane (PE-PUR) foam.  The foam part is used to dampen the sound of the machine

The problems reported with the Philips Respironics BiPAP and CPAP devices are twofold:

 1.       The foam degrades over time.  Particles of the foam may break away and can directly enter the patients’ airways, ultimately lodging in the lungs.

2.       The foam outgases two caustic, toxic chemicals (gasses), which are inhaled by users.  The outgas occurs starting with the first use of a new unit and continues to the last use.

Problem 1 – Foam Dust

When these (PE-PUR) foam dust lodge in the lungs, the human body will react in one of two ways:

1. The body will attempt to encapsulate the dust particle, which would increase the probability of cancer at the site of the particle (lungs).

2. If the body is unable to encapsulate the particle, the dust particle continues to break down and is absorbed in the blood stream, and the foam dust toxins are then passed to every organ and anatomical structure of the human body.

Problem 2 – Toxic Outgas

Philips’ warns doctors that these chemicals can cause airway inflammation, which is particularly dangerous for patients who have reduced cardiopulmonary reserve or underlying lung illnesses and diseases.

The reported toxic “gases” which users of the recalled devices were exposed via inhalation included:

1. Dimethyl Diazine: Other names include: Azomethane; (CH3N)2; 1,2-Dimethyldiazene; Dimethyldiazene

2. Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) (also called carbolic acid)

How bad are the chemicals in the foam?

Exposure to low doses of Dimethyl Diazine is known to cause a variety of health injuries, especially in the kidneys or liver (including organ failure and cancers in these organs); the kidneys and liver are where Dimethyl Diazine is filtered in the body.

One definite known health risk regarding Phenol is that the substance is highly caustic. Phenol will cause chemical burns on human skin (epithelia cells) if not quickly treated. Epithelia cells are also in the lungs.

Epithelial cells of the lung are located between the outside air and the lung tissue, and help with barrier protection, fluid balance, clearance of particulate, initiation of immune responses, mucus and surfactant production, and repair following injury.

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The units that are subject to the recall:

Philips recently launched the next-generation CPAP platform, DreamStation 2, which uses different foam.  This unit is not affected by the issue.  Philips is increasing the production of its DreamStation 2 CPAP devices, which are available in the U.S. and selected countries in Europe.

Continuous Ventilator

  • Trilogy 100
  • Trilogy 200
  • Garbin Plus, Aeris, LifeVent

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

  • A-Series BiPAP Hybrid A30 (not marketed in US)
  • A-Series BiPAP V30 Auto

Continuous Ventilator, Non-life Supporting

  • A-Series BiPAP A40
  • A-Series BiPAP A30

All Devices manufactured before April 26, 2021

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

  • E30 (Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+

Noncontinuous Ventilator

  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go
  • Dorma 400
  • Dorma 500
  • REMstar SE Auto

Important information about the recall:

Do not stop or alter your prescribed therapy until you have talked to your physician.

Register your device(s) on the recall website www.philips.com/src-update

The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two issues.

The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.

Call 1-877-907-7508 if you cannot visit the website or do not have internet access.

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What You Can Do & How We Can Help

Aaronson & Rash, PLLC was founded in 2005.  We handle cases nationwide from our principal office in Houston, Texas. 

At Aaronson and Rash, PLLC, our attorneys are here to help you.  We have over 40 years of combined experience in personal injury, environmental disasters, defective products, pharmaceutical litigation, and toxic exposure cases. Our legal team is ready to work with you and your family as we fight for the maximum compensation you deserve.

Bilingual staff is available for Spanish clients. At Aaronson & Rash, we believe that everyone deserves an experienced attorney, no matter their financial circumstances. That’s why we only accept cases on a contingency fee basis. Rather than an hourly legal fee, a contingency fee arrangement means that the attorney will not receive any payment until the completion of the lawsuit and only if the suit is successful.

We offer 100% free and confidential case evaluations. If you would like more information, click on the CONTACT button or call our offices at 844 THE LAW 4 (844-843-5294) for a FREE CASE EVALUATION from our experienced attorneys.

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Important:  There are strict time deadlines for filing your claim, ACT NOW