On June 14, 2021, Philips Respironics issued a recall notification because of potential health risks associated with the polyester-based polyurethane (PE-PUR) sound reduction foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, as well as certain mechanical ventilators. Philips acknowledged that the PE-PUR foam may degrade or fall apart into tiny black particles that can enter the device’s humidifier, tubing and mask and be ingested or inhaled by the user. Testing by Philips also found that the foam can produce unsafe chemical levels that are released as gases.
The particulate and off-gas chemical exposure can result in serious injury which can be life-threatening, cause permanent impairment, or require medical intervention to prevent permanent injury. Philips admits to receiving complaints regarding the presence of black debris/particles within the “airpath circuit” which extends from the device outlet, humidifier, tubing, and mask. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Potential risks of particulate exposure include irritation to the respiratory tract, inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. The potential risks of chemical exposure due to off-gassing include headache/dizziness, respiratory tract irritation, hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. According to Philips, there have been no reports of death as a result of these issues.
The following CPAP and Bi-Level PAP Devices have been recalled:
(All Devices manufactured before April 26, 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
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto
The following mechanical ventilators have been recalled:
(All Devices manufactured before April 26, 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
If you have been affected by the Philips Respironics CPAP recall, you should take the following steps immediately:
