Philips recalled millions of CPAP Machines, BiPAP Machines, DreamStation Sleep Apnea Machines, and Ventilators because users can breathe toxic foam that can cause cancer and other side effects.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Philips CPAP and sleep apnea machine induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer or other toxic side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: Philips EVO Ventilator Recall
In January 2022, Philips Respironics issued a Class 1 recall for certain EVO Ventilators and repair kits because a supplier incorectly used PE-PUR foam, which puts users at risk of health problems. The recalled ventilators are also known as “hospital-to-home” ventilators because they can be used in hospitals, at home, or in non-emergency transport settings, like wheelchairs or personal vehicle.
Class 1 Recall for Philips Breathing Machines
On July 22, 2021, the FDA issued Class 1 recalls for more than 3.5 million Philips ventilators and CPAP and BiPAP machines that pose serious health risks, including cancer, due to toxic PE-PUR foam disintegrating in the machine and getting into the air that a user breathes. About 3.5 million Philips breathing machines have been sold since 2009.
How Many People Have Been Injured?
The FDA has received more than 1,200 complaints and over 100 injury reports linked to have toxic PE-PUR foam in a recalled Philips breathing machine, according to MassDevice.
According to the FDA, the serious health risks linked to PE-PUR foam include:
“The exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects.”
Philips CPAP Lawsuit Filed in Massachusetts
Philips has been hit with a class action lawsuit in Massachusetts by lawyers who accuse Philips of delaying a massive recall on CPAP Machines and other breathing devices.
The lawsuit was filed by Gerry S., a truck driver with sleep apnea who could not work because it was unsafe to drive with untreated sleep apnea. Like many other victims, he had no replacement for his CPAP Machine after it was recalled.
The lawsuit warns that some people with untreated sleep apnea may develop may experience “severe symptoms, including heart attack, stroke, and death by asphyxiation.” Philips is also accused of failing to warn the public until April 2021, despite years of complaints from patients who noticed black particles of foam.
The Philips CPAP Lawsuit was filed on June 29, 2021 in the U.S. District Court for the District of Massachusetts — Case Number 1:21-CV-11076.
Philips Recalls 4 Million Breathing Machines for Toxic Health Risks
In June 2021, Philips recalled around 4 million breathing machines because users can develop cancer and other health problems. The air a user breathes passes through the same tube that contains a toxic “sound-abatement” foam. This foam can disintegrate into tiny bits that a user can breathe or swallow, resulting in health problems. The foam can also release toxic gases, known as Volatile Organic Compounds (VOCs).
What is the Problem?
Philips received several complaints of black foam debris or particles in the air-path circuit that users breathe. “Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection,” according to the Medical Device Recall Notification.
What Breathing Machines Were Recalled?
The recall involves millions of breathing machines, including products that are used to treat sleep apnea, as well as life-saving mechanical ventilators. These products include:
- DreamStation machines
- Continuous Positive Airway Pressure (CPAP)
- Bi-Level Positive Airway Pressure (Bi-Level PAP)
- Mechanical ventilators
Toxic Foam Linked to Cancer & Health Problems
The problem has been linked to a toxic foam known as polyester-based polyurethane (PE-PUR), which is a “sound abatement” foam that is used to reduce noise. Unfortunately, the foam can “degrade” into tiny particles that users can breathe or ingest. The foam can also “off-gas” toxic chemicals, posing additional health risks.
Toxic Foam Problems Linked to Design Flaws
The problem is linked to the design of Philips’ breathing machines, in which the air passes over the foam through a tube. Instead of fixing this design on newer products, Philips simply switched out the foam.
Health Risks of Exposure to Toxic Foam in Philips Breathing Machines
- Cancer
- Coughing
- Headaches
- Chest pain
- Irritation (skin, eye, and respiratory tract)
- Asthma
- Organ damage (e.g., kidneys and liver)
- Sinus Infections
- Breathing problems
- Inflammatory response
- Nausea and vomiting
- And more
List of Products in Philips DreamStation Recall / CPAP and BiLevel PAP Recall
Continuous Ventilator, Minimum Ventilatory Support, Facility Use:
- E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- OmniLab Advanced Plus In-Lab Titration Device
Non-continuous Ventilator:
- SystemOne (Q series)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO APAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
List of Products in Philips Ventilator Recall
Continuous Ventilator:
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Trilogy EVO Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use:
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto Ventilator
Continuous Ventilator, Non-life Supporting::
- A-Series BiPAP A40 (not marketed in US)
- A-Series BiPAP A30 (not marketed in US)
Do I have a Philips CPAP and Sleep Apnea Machine Lawsuit?
The Schmidt Firm, PLLC is currently accepting Philips CPAP and sleep apnea machine induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer or other toxic side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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