On June 14, 2021, manufacturing giant Philips issued a recall on their commonly-used Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), and Adaptive-Servo Ventilation (ASV) devices, which are used to treat sleep apnea. Millions of the Philips CPAP, BiPAP, and ventilator devices were recalled after the discovery of the polyester-based polyurethane (PE-PUR) sound abatement foam being linked to an uprise in lung cancer, breast cancer, pancreatic cancer, kidney cancers, leukemia, liver cancer, thyroid cancer, and many other life-threatening cancers.
In addition to the numerous carcinogenic risks, the CPAP, BiPAP, and ventilator devices have led to a vast array of toxic chemical exposure-related injuries and serious respiratory issues. The FDA has recorded over 100 injuries and 1,200 complaints since Phillips issued their recall. There have yet to be any reports of death as a result of these issues.
How Many CPAP, BIPAP, & Ventilation devices were recalled?
According to Philips’ production & shipment data, approximately 3 million to 4 million devices were recalled globally. The devices that were recalled were distributed between July 2009 and April 2021. This recall consists primarily of first-generation DreamStation machines. DreamStation 2 machines and users are not currently known to be affected.
What are the dangers of the recalled CPAP, BiPAP, and Ventilation Machines?
What makes the recalled devices so harmful is the disintegrating polyurethane foam inside the breathing devices. As this foam decomposes, it emits toxic gases that can be harmful or even fatal to users of the recalled devices. Chemicals that are emitted when polyurethane foam decomposes include the following: Formaldehyde, Methylene Chlorine, Benzene, Solvents, Perfluorooctane sulfonate, volatile organic compounds, and flame retardant. These chemicals are known to cause various cancers, inflammation, irritation, learning disabilities, lower IQ levels, damage to cellular DNA.
List of Recalled Philips CPAP, BiPAP, and Ventilators
On June 14, 2021, Philips issued a recall on the following devices:
• System One 50 series CPAPs, Auto CPAP, BiPAPs
• System One 60 series CPAPs, Auto CPAP, BiPAPs
• DreamStation CPAP, Auto CPAP, BiPAP
• DreamStation GO CPAP, APAP, Auto CPAP
• Dorma 400, 500 CPAP, Auto CPAP (not marketed in US)
• System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
• System One BiPAP autoSV, System One BiPAP autoSV Advanced
• DreamStation BiPAP autoSV ASV
• DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
• E30 (Emergency Use Authorization)
• OmniLab Advanced Plus
• Trilogy 200 Ventilator
• Trilogy 100 Ventilator
• Garbin Plus, Aeris, LifeVent Ventilator (not marketed in US)
• A-Series BiPAP V30 Auto Ventilator Also known as BiPAP V30 Auto Ventilator
• BiPAP Hybrid A30 Ventilator (A-Series) (not marketed in US)
• A-Series BiPAP A40 Ventilator (not marketed in US)
• A-Series BiPAP A30 Ventilator (not marketed in US)
Devices that are not affected by the recall and why?
Some Philips CPAP, BiPAP, and Ventilation devices are not affected by the recall because newer generation devices may utilize different sound abatement foam materials and technologies that have become available. For other unaffected devices, sound abatement foam may be placed in a different location due to their modernized device designs.
Devices unaffected by the recall include:
• Trilogy Evo
• Trilogy Evo OBM
• Trilogy EV300
• Trilogy 202
• A-Series Pro and EFL
• Respironics M-Series REMStar CPAPs, Auto CPAPs, BiPAPs
• DreamStation 2 Auto CPAP Advanced and DreamStation 2 Auto CPAP
• Omnilab and OmniLab Advanced Titration devices
• V60 Ventilator
• V60 Plus Ventilator
• V680 Ventilator
• REMStar SE and Sleep Easy CPAPs
• Dorma 100, Dorma 200 CPAPs (not marketed in US)
• All oxygen concentrators, respiratory drug delivery products, airway clearance products.
What should I do if My CPAP, BiPAP, or Ventilation Device has been recalled?
According to Philips, anyone using BiLevel PAP and CPAP devices should immediately stop using these devices and talk with their doctors about safer alternatives. However, patients using life-sustaining devices should NOT stop using them but should immediately talk with their physicians to discuss the risks and determine what steps should be taken.
What if I have been diagnosed with Cancer or Sustained a Respiratory Injury, and I have used a Philips Recalled Sleep Apnea or Ventilation Device?
If you have been diagnosed with breast cancer, thyroid cancer, leukemia, lymphatic cancer, liver cancer, nasal cancer, lung cancer, non-Hodgkin’s lymphoma, brain cancer, multiple myeloma, prostate cancer, bladder cancer, testicular cancer, stomach cancer, hematopoietic cancer, or papillary carcinoma and have used a recalled Philips CPAP or another breathing device, call Phillips Law Offices at (312) 346-4262 to speak with a products liability attorney today. Our experienced attorneys have successfully litigated products liability cases for over seven (7) decades, and we are here to help.