Medical technology manufacturer Philips issues recall on CPAP, BiPAP, and ASV machines as research suggest toxic polyurethane foam emits cancer-causing particles and gases.
Millions of sleep apnea treatment devices have been recalled by Philips following internal research discovering the foam each machine is fitted with releases toxic particles and “off-gasses” as it decomposes. The toxins were found to cause a multitude of adverse symptoms and potentially even cancer in users, particularly lung cancer and leukemia.
According to Philips, all of the affected devices were manufactured before April 26, 2021, irrespective of individual serial numbers. The specific products included in the recall are the following:
- E30 Continuous Ventilator
- DreamStation ST, AVAPS
- DreamStation ASV
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP
- OmniLab Advanced Plus In-Lab Titration Device
- C Series ASV, S/T, AVAPS
- SystemOne ASV4
- SystemOne Q Series
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- Garbin Plus, Aeries, LifeVent Ventilator
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- A-Series BiPAP V30 Auto Ventilator
- A-Series BiPAP Hybrid A30 (not marketed in the US)
- A-Series BiPAP A40 (not marketed in the US)
- A-Series BiPAP A30 (not marketed in the US)
The issue of airborne hazards is two-fold, presenting itself as volatile organic compounds (VOCs) and other particulate matter.
Polyurethane foam degrades due to factors like heat, oxygen, sunlight, bacteria, and fungus. As it disintegrates it hardens before crumbling apart. As the particles break off, they are propelled by the air being pumped through the machine into patients, where they are a serious hazard. While this process occurs, the foam discolors, from off-white to yellow, then to a reddish-brown, and finally to the black particles users unknowingly inhale or ingest.
It is important to note that some users may not have found any visible particulate matter. However, this does not mean their devices are safe to use. Lab testing has found that where bad foam is present so too are concerning chemicals like Toluene Diisocyanate, which the European Union considers “highly toxic” and too dangerous even in hair dye.
In addition to the particulate matter, the foam may be emitting noxious gases in the form of VOCs. Like the particles, VOCs may be inhaled or ingested through the airways, but unlike the solid particles, these emissions may also be absorbed through the skin and tissues into the bloodstream.
Exposure to these particles and fumes puts consumers at risk for irritation in the respiratory tract, eyes, nose, and skin, in addition to headaches, nausea and vomiting, hypersensitivity, and other carcinogenic effects. The aforementioned symptoms are all aggravators of any underlying conditions a user may have been suffering from already, adding to the gravity of the situation.
Exposure to off-gassing also puts users at risk or increases their risk of various cancers. Lung cancer, leukemia, breast cancer, and liver cancer are just a few of the illnesses that may be caused by exposure to chemicals like benzene, formaldehyde, and flame retardant, all of which are found in degrading polyurethane foam.
At Rheingold, Giuffra, Plotkin & Ruffo, our attorneys are investigating CPAP, BiPAP, and ASV cases and continue to speak with people who have used these dangerous devices. Our aggressive representation of our clients has allowed us to recover over $2 billion in medical malpractice, mass tort, personal injury, and product liability cases, including cancer-causing Talcum Powder, Zantac, Valsartan, and Actos. If you or a loved one has used one of these devices and want to know if you can take legal action call (212) 684-1880 to speak with us directly and receive a free consultation.