Philips recalled 4 million breathing machines because toxic foam may cause cancer or other side effects. The recall involves ventilators, CPAP, BiPAP and DreamStation sleep apnea machines.
Need a Texas Philips CPAP & Sleep Apnea Machine Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with cancer or other severe side effects of using a recalled Philips CPAP machine, DreamStation, sleep apnea machine, or ventilator, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: 385 Deaths Linked to Philips CPAP Machines
On June 2, 2023, the FDA posted an Update on the Philips CPAP Recall.
Since April 2021, the FDA said it has received reports of 385 deaths and more than 105,000 medical device reports (MDRs) involving serious injuries, such as:
- Cancer
- Pneumonia
- Asthma
- Other respiratory problems
- Infection
- Headache
- Cough
- Difficulty breathing
- Dizziness
- Nodules
- Chest pain
Philips EVO Ventilator Recall
In January 2022, Philips Respironics issued a Class 1 recall for certain EVO Ventilators after a supplier incorrectly used toxic foam (PE-PUR foam) that poses health hazards to users. The recall involves ventilators with Material Number DS2110X11B (USA).
Class 1 Recall for 3.5 Million Philips Breathing Machines
On July 22, 2021, the FDA issued Class 1 recalls for millions of Philips ventilators and CPAP and BiPAP machines due to a risk of cancer and other health problems from toxic PE-PUR foam breaking down and releasing cancer-causing gases. Over 3.5 million of the recalled machines have been sold since 2009.
How Many People Have Been Injured?
The FDA has received reports of around 400 deaths and over 100,000 complaints of injuries involving toxic PE-PUR foam breaking down in a Philips breathing machine.
In the Class 1 recall notice, the FDA warned about the following health risks:
“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 Recalls 4 Million Breathing Machines for Toxic Health Risks
June 2021 — Philips recalled 4 million breathing machines due to a risk of cancer and other severe side effects linked to toxic foam.
What is the Problem?
The air that a user breathes passes through a tube that contains a toxic “sound-abatement” foam. This problem is that this foam can disintegrate and release tiny particles that a user breathes or ingests. The foam itself is carcinogenic. It can also “off-gas” toxic chemicals.
Philips Recalls Breathing Machines After Complaints
Philips recalled the breathing machines after customers complained about finding tiny pieces of foam in the air-path circuit. There were also complaints of health problems, according to the Medical Device Recall Notification: “Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.”
Was Your Breathing Machine Recalled?
Philips mostly recalled DreamStation machines, which are used for sleep apnea, but the company also recalled some mechanical ventilators, Bi-Level Positive Airway Pressure (Bi-Level PAP), and Continuous Positive Airway Pressure (CPAP) machines.
Recalled Breathing Machines Contain Toxic Foam
The recalled breathing machines contain a type of foam called polyester-based polyurethane (PE-PUR). Unfortunately, the foam can disintegrate into tiny particles that a user might breathe or swallow. Philips also warned that the foam can also “off-gas” toxic chemicals.
Health Hazards Linked to Flawed Design
Philips designed the breathing machines with toxic foam inside the same tube that the air passes through — with nothing sealing off the foam from the air. Instead of fixing this issue on newer, non-recalled breathing machines, Philips simply changed the type of foam.
What is the Risk?
- Cancer
- Kidney failure
- Liver failure
- Coughing
- Headaches
- Chest pain
- Irritation to the skin, eyes, throat, nose, and lungs
- Asthma
- Organ damage (e.g., kidneys and liver)
- Sinus infections
- Breathing problems
- Hypersensitivity
- Nausea or vomiting
- And more
What CPAP & Sleep Apnea Machines Were Recalled?
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
What Ventilators Were Recalled?
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)
Need a Philips CPAP and Sleep Apnea Machine Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.
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