Philips Respironics URGENT: Medical Device Recall CPAP and Bi-Level PAP Devices

woman sleeping using CPAP machine

Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission

Philips Respironics has issued an urgent medical device recall of multiple CPAP and BiPAP ventilators. The action is the company’s response to 2 known issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in the devices. These issues can lead to serious, possibly life-threatening injury or permanent impairment.

The PE-PUR foam may degrade into dangerous particles which can enter the device’s air pathway and be ingested or inhaled by users. To date, Philips Respironics has received numerous complaints of black debris/particles in the airpath tubing, mask, humidifier, and device outlet.

Risks of Particulate Exposure Include

  • Irritation (skin, eye, and respiratory tract)
  • Inflammatory response
  • Headache
  • Asthma
  • Adverse effects to other organs (e.g., kidneys and liver)
  • Toxic carcinogenic effects

PE-PUR foam has the potential to emit harmful gases called volatile organic compounds (VOCs). According to Philips Respironics these VOCs can include diethylene glycol, Toluene Diisocyanate, Toluene Diamine, Phenol Dimethyl Diazine. To date, Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.

Risks of Chemical Exposure Due to Off-gassing Include

  • Headache/dizziness
  • irritation (eyes, nose, respiratory tract, skin)
  • Hypersensitivity
  • Nausea/vomiting
  • Toxic carcinogenic effect

Recalled BiPAP and CPAP Devices

 All Devices Manufactured Before 26 April 2021, All Serial Numbers

Continuous Ventilator
Trilogy 100
Trilogy 200
Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP Hybrid A30 (not marketed in US)
A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40
A-Series BiPAP A30

 All Devices Manufactured Before 26 April 2021, All Serial Numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
Noncontinuous Ventilator
SystemOne (Q-Series)
DreamStation Go
Dorma 400
Dorma 500
REMstar Auto

Download the full Philips Respironics Urgent Medical Device Recall Notice

Philips Respironics User Experiencing Adverse Effects? We Can Help.

If you have been using the one of the recalled Philips Respironics CPAP or BiPAP ventilator devices and are experiencing adverse effects, you may be entitled to compensation. Click, Chat, or call 1800LAW1010 24/7 for a free case evaluation.

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