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Medical device maker Philips announced a voluntary recall of sleep apnea machines and ventilators due to toxic foam material that may put users at risk of cancer and other health issues. 

The recall includes millions of units of the Philips Bi-level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. Most of these recalled devices are DreamStation products.

Consult a Medical Device Liability Attorney

Under federal regulation, consumers are entitled to a level of safety from the manufacturers of the products they buy, especially when these products are marketed to enhance an individual’s quality of life. If you or someone you love has used or been affected by a recalled Philips Bi-Level PAP or CPAP machine, you may be entitled to compensation through a class action lawsuit. Consult with an experienced Medical Device Liability attorney at Sullivan Papain McGrath Coffinas and Cannavo P.C by calling 212-732-9000 or filling out the form below. for your free consultation. 

Potential Foam Degradation

While there have not been any deaths linked to the PE-PUR foam disintegration yet, Philips acknowledged the potential risks of exposure to the foam particles. Phillips also recognized that the foam may off-gas certain chemicals. Headaches, irritation, inflammation, hypersensitivity, nausea/vomiting, respiratory issues and possible toxic and carcinogenic effects were all concerning symptoms that led to the recall.

Affected Devices

It is estimated that between 3 million and 4 million devices will be affected by the recall. Philips’ company spokesman Steve Klink stated that approximately 80% of the affected machines are CPAP machines, which treat people suffering from sleep apnea. The remaining 20% of the recalled machines are ventilators. 

The recalled devices include the following. All recalled units were manufactured before April, 26 2021 and all device serial numbers are affected. 

Philips’ Noncontinuous Ventilators

  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go Dorma 400
  • Dorma 500 REMstar SE Auto

Philips’ Continuous Ventilators 

  • Trilogy 100
  • Trilogy 200
  • Garbin Puls, Aeris, LifeVent

Philip’s Continuous Ventilator, Minimum Ventilatory Support, Facility Use 

  • A-Series BiPAP Hybrid A30 (not marketed in the US)
  • A-Series BiPap V30 Auto 

Philips’ Continuous Ventilator, Non-life supporting 

  • A-Series BiPAP A40 (not marketed in the US) 
  • A-series BiPAP A30 (not marketed in the US) 

Philips DreamStation CPAP Machines 

  • DreamStation
  • DreamStation ASV
  • DreamStation GoDorma 400 
  • DreamStation ST, AVAPS 

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