Which CPAP Machines Did Philips Recall?
According to the U.S. Food and Drug Administration (FDA), the following Philips CPAP machines, BiPAP machines, and ventilators have been recalled:
Recalled CPAP and BiPAP Products:
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)
OmniLab Advanced+
REMstar SE Auto
SystemOne (Q-Series)
SystemOne ASV4
Recalled Ventilators:
A-Series BiPAP A30
A-Series BiPAP A40
A-Series BiPAP Hybrid A30*
A-Series BiPAP V30 Auto
Garbin Plus, Aeris, LifeVent
Trilogy 100
Trilogy 200
*not marketed in the U.S.
Why Are CPAP Sleep Apnea Machines Recalled?
Philips determined a recall was appropriate after receiving user reports and conducting lab testing on several CPAP, BiPAP, and ventilators, including the widely-used Philips DreamStation. The company found that the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips sleep machines can degrade and deteriorate over time, which can cause people who rely on these machines for breathing assistance to inhale or ingest small particles or gas.
Inhaling or ingesting PE-PUR particulate can cause a host of health issues. Philips has already acknowledged that the risks of particulate exposure include:
- Adverse effects to kidneys and liver
- Asthma
- Headache
- Inflammatory response
- Irritation (eye, respiratory tract, and skin)
- Respiratory issues
- Toxic carcinogenic effects
According to Philips, the foam degradation may worsen in certain conditions, including higher temperatures and humidity, and the use of unapproved cleaning methods (including ozone).
Class-Action Lawsuit Alleges Philips Knew for Years That CPAP Machines Were Dangerous
Shortly after the FDA CPAP recall, a class-action lawsuit was filed alleging Philips knew that its CPAP machines were dangerous years before the company decided to issue its recall. The class-action alleges that numerous people had complained to Philips in the years before the recall noting that they found “black particles” in their sleep machines, including the company’s flagship DreamStation line of CPAP machines.
Rather than issuing a warning to consumers, the class-action lawsuit alleges that Philips continued to sell its line of CPAP, BiPAP, and ventilators until it could launch a new generation of CPAP, BiPAP, and ventilator machines to replace the recalled machines. Considering how many people rely on these machines each and every day, our law firm is appalled by Phillips’ alleged actions.
CPAP Lawsuit FAQ
What is a CPAP Machine?
CPAP (continuous positive airway pressure) machines are medical devices used to treat people with obstructive sleep apnea. CPAP sleep machines send a steady flow of oxygen to the nose and mouth, keeping the airway open and allowing the patient to breathe normally. CPAP machines have motors that generate oxygen, which travels through a filter and a flexible tube before reaching the mask, sealed around the patient’s nose and mouth.
What is the Difference Between CPAP and BiPAP?
They may look similar, but BiPAP (bilateral positive airway pressure) machines differ from CPAP machines. BiPAP machines are more complex than CPAP machines in that they have two pressures (inhalation and exhalation) compared to the CPAP’s one pressure. BiPAP therapy is the preferred treatment method for people who do not respond to CPAP therapy, including those with central sleep apnea, complex sleep apnea, or chronic obstructive pulmonary disease (COPD). BiPAP machines are generally more expensive than CPAP machines, so many people who can be treated by either choose CPAP instead of BiPAP.
What is Sleep Apnea?
Sleep apnea is a serious sleeping disorder where a person’s breathing repeatedly starts and stops. It is the most common sleeping disorder in the U.S.
There are three types of sleep apnea:
- Obstructive Sleep Apnea – Obstructive sleep apnea happens when an individual’s throat muscles intermittently relax, blocking the airway during sleep. It is the most common type of sleep apnea, affecting an estimated one in 15 people in the U.S.
- Central Sleep Apnea – Central sleep apnea happens when an individual’s brain does not send the proper messages to the muscles that control breathing. This study estimates that .9% of people over 40 have central sleep apnea.
- Complex Sleep Apnea Syndrome – Complex sleep apnea, also known as treatment-emergent central sleep apnea, occurs when a person presents with both obstructive sleep apnea and central sleep apnea.
How Do Philips Breathing Machines Cause Cancer?
The polyester-based polyurethane foam used in the recalled Philips breathing machines may degrade over time. This degradation may allow particles to flow into the affected CPAP, BiPAP, and ventilator air pathways, which then causes the person using the device to breathe in the particles. As Philips said in its clinical information, the “absence of visible particles does not mean that foam breakdown has not already begun.” This means that even if you can’t see foam degradation on your sleeping machine, you still may be inhaling toxic particles. Philips has already admitted the presence of the following:
- Toluene Diamine: According to the U.S. Environmental Protection Agency (EPA), in animal studies, toluene-2,4-diamine was found to be a carcinogen following dietary administration. EPA noted a significant increase in the incidence of a many different tumor types, including liver, mammary gland, subcutaneous fibromas, lung lymphomas, and leukemia.
- Toluene Diisocyanate (TDI): The International Agency for Research on Cancer (IARC), the gold standard for carcinogenicity testing, classifies TDI as a possible human carcinogen. IARC came to its conclusion based on sufficient evidence in experimental animals and inadequate evidence in humans. This study notes that TDI is a “well-known sensitizer and cause of occupational asthma.”
- Diethylene Glycol: Associated with renal failure (acute kidney injury).
- Dimethyl Diazene: Also known as azomethane. The oxide derivative of this compound is azoxymethane, a known carcinogen.
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl): According to EPA, Phenol is considered toxic to humans via oral exposure. Anorexia, a dark coloration of the urine, diarrhea, progressive weight loss, salivation, vertigo, and blood and liver effects have been reported in chronically (long-term) exposed humans. Animal studies have shown reduced fetal body weights, growth retardation, and abnormal development in the offspring among animals exposed to phenol by the oral route.
Can I File a CPAP Lawsuit Against Philips?
If you were diagnosed with cancer after using one of the affected Philips recall products above, you may be eligible to pursue compensation in a CPAP lawsuit. The fastest way to find out more about your eligibility is to contact our firm as soon as you are able. Our legal team will evaluate your case and let you know if you can proceed with a claim.
If you are interested in learning more about pursuing a lawsuit against Philips, contact us today or call (855) 948-5098. Our class-action attorneys offer free and confidential CPAP lawsuit case evaluations.
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