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Philips Respironics CPAP Machine Recall Lawsuits

Philips CPAP Machine Recalls

Toxic Inhalants Found in CPAP Machines

Several Philips Respironics machines commonly used for sleep apnea treatment have been recalled on June 2021 due to potential health risks. Users of these machines could potentially be exposed to toxic chemicals and carcinogens through a foam that’s used in the affected devices as part of nightly sleep apnea treatment.

This foam, also known as PE-PUR (polyester-based polyurethane sound abatement foam), is typically used to reduce sound and vibration that the CPAP machines may cause.  That sounds nice except the FDA reports that this foam “may break down… and potentially end up being inhaled or swallowed by the users”, per the Food and Drug Administration safety statement on June 30th, 2021.

Then just some weeks later, July 2021, the FDA issued an official Class I recall for several Philips CPAP, Philips BiPap, and various other Philip sleep machines which we will list below.

Why CPAP Machines have Class I Recall

The issue with the Philips machines is that the foam meant to lower sound levels the machines can create are prone to degrading and breaking down which could contaminate the machine’s air pathway with particles and chemical emissions released.

Many users report seeing black debris and specks in their machine which they are then unknowingly inhaling and swallowing inside their bodies. Some of the healthcare issues which we will get into can lead to serious injury, permanent damage, and could even be life-threatening.

What is a Class I Recall?

A Class I recall is the most urgent recall type, typically indicating that the use of a certain product or machine may lead to significant injuries and/or death. If this is such a concern, then a likely question that arises is: Why use this foam? 

Well, those who are familiar with this type of medical device understand that BiPAP machines and CPAP machines (continuous positive airway pressure) can be very uncomfortable equipment to use, especially when the user is a light sleeper or needs as little sound as possible before falling and staying asleep.  

Cancer-Causing Effects from Recalled Phillips Machines

Along with the Philips recall notification, the FDA also shared reported symptoms and the potential unintentional side effects for patients using these Bi-Level PAP (bi-level positive airway pressure) machines and CPAP devices in the FDA’s safety communication. Below, we compiled available information on the more frequently seen symptoms associated with these recalls.

“Minor Symptoms”

Common Symptoms from Philips Foam Degradation

Sinus Infection

Skin Irritation

Eye Irritation

Nasal Irritation

Respiratory Tract Irritation

Headache

Dizziness

Hypersensitivity

Nausea-Vomiting

A veteran suffers from several service connected disabilities such as diabetes and diabetic retinopathy and neuropathy. These disabilities arise from a common cause (the diabetes). Therefore, these ratings need only combine to a 60% evaluation in order for the veteran to qualify for IU.

“Severe Symptoms”

Medical Conditions associated with Defective Philips Foam

Lung Damage

Lung Cancer

Severe Respiratory Failure / Asthma

Pneumonia

Colon Cancer

Kidney Cancer

Liver Cancer

Increased risk of Stroke

A veteran has ratings of 40% for a Lumbar Spine condition, 30% for a knee, and 30% for his PTSD.  VA’s combined rating math, results in a 70% rating. Since the veteran’s spine is rated at 40% and he has a 70% total rating, he meets  IU.

What Philips Sleep Apnea Machines have been recalled?

1

Philips Continuous Mechanical Ventilators Recalled

  1. Trilogy 100 Ventilator
  2. Trilogy 200 Ventilator
  3. Garbin Plus, Aeris, LifeVent Ventilator (not marketed in US)
  4. A-Series BiPAP Hybrid A30 (not marketed in US)
  5. A-Series BiPAP V30 Auto Ventilator
  6. A-Series BiPAP A40A-Series BiPAP A30

2

Philips CPAP Machine and Bi-Level PAP DreamStation Device Recalls

  1. E30 (continuous ventilator, minimum  ventilatory support, facility use)
  2. DreamStation ASV
  3. DreamStation ST, AVAPS
  4. SystemOne ASV4
  5. C Series S/T, AVAPS
  6. OmniLab Advanced Plus
  7. System One 50 series
  8. System One 60 series
  9. DreamStation CPAP, Auto, CPAP, BiPAP
  10. DreamStation GO CPA, APA, Auto, CPAP
  11. Dorma 400, 500 CPAP, Auto CPAP

3

Which Philips CPAP Machines Have NOT Been recalled and are still in-market?

  1. Trilogy Evo
  2. Trilogy Evo OBM
  3. Trilogy EV300
  4. Trilogy 202
  5. A-Series Pro and EFL
  6. Respironics M-Series REMStar CPAPs, Auto CPAPs, BiPAPs
  7. DreamStation 2 Auto CPAP Advanced and DreamStation 2 Auto CPAP
  8. Omnilab and OmniLab Advanced Titration devices
  9. V60 Ventilator
  10. V60 Plus Ventilator
  11. V680 Ventilator
  12. REMStar SE and Sleep Easy CPAPs
  13. Dorma 100, Dorma 200 CPAPs (not marketed in US)
  14. All oxygen concentrators, respiratory drug delivery products, airway clearance products.

Common Philips CPAP Recall Questions

The following issues have been directly linked with increasing the odds of a malfunction and foam degradation in Philips CPAP respironics machines:

  • High heat storage
  • High humidity storage
  • Improper cleaning methods of the CPAP and/or mechanical ventilator device
  • Incorrect cleaning products 

To put things in perspective, there are approximately 4 million Philips machines that use this PE-PUR foam we’ve been discussing. Another shocking statistic that many Americans may not know is that Phillips Respironics is estimated to hold approximately two-thirds (about 65%) of the CPAP industry and market.

These news are absolutely devastating to approximately two million Americans who may now find themselves being forced to switch their sleep apnea treatment in order to avoid serious injury. 

Consider this: the VA has issued an estimated 600,000 or so of these Philips CPAP machines and Philips BiPAP Machines to our nation’s veterans for home use. As VA disability attorneys, we speak to veterans with sleep apnea every single day. This is a very pressing issue that is extremely prevalent among veterans. Below, we’ll address the official list of affected devices from the Philips statement.

Don’t believe us, let’s check the source directly. In Fiscal Year 2020, the VA’s Annual Benefit Report shows that 403,483 American veterans have service connected sleep apnea! Think about the ones who are still fighting to get their sleep apnea service connected for benefits. These veterans are usually prescribed a respironics machine for sleep apnea treatment.

Yes, at least that’s the plan per a significant update we got directly from Philips Respironics in September 2021. Philips Respironics announced at the beginning of the month, that they “intend to complete their repair and replacement program within 12 months” so the clock is ticking.

Talk to your medical professional about your concerns with the Philips CPAP recall if you’ve been prescribed one of these machines for treatment. You should ALWAYS consult with your medical care provider before taking any immediate action on your respiratory care.  The FDA recommends writing down your device’s serial number for future reference and signing up on the Philips recall notice website for the latest updates on replacement devices and repairs. 

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Sources:

https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

https://www.benefits.va.gov/REPORTS/abr/

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