Philips Respironics has voluntarily recalled their CPAP machines, BiPAP machines and ventilators due to foam particles that could increase the risk of cancer and other serious health problems. The recall was due to evidence that the sound abatement foam used to reduce sound and vibration, or polyester-based polyurethane (PE-PUR) foam, in affected devices, could break down into particles and potentially enter the device’s air pathway.
Black debris from the foam or certain chemicals released could be inhaled or swallowed by the patient using the device. Foam degradation may be accelerated through unapproved cleaning techniques, including ozone. High heat and humid conditions could also lead to foam degradation.
“The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver…The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.” – FDA notifies the public of recall
About 80 percent of the affected devices were CPAP (continuous positive airway pressure) machines used by people diagnosed with sleep apnea. Ventilators account for the other 20 percent, with some BiPAP (bi-level positive airway pressure) machines also being recalled. The June 2021 recall only affects units sold in the U.S. Around two-thirds of the Philips CPAP machines were sold in the U.S.
Philips has received reports of possible patient harm due to foam degradation, but there have been no reports of death to date. Individuals who have used one of these defective machines for at least three months are at risk of developing any of the following conditions:
Philips has manufactured millions of Bi-Level PAP, CPAP, and mechanical ventilator devices utilizing PE-PUR sound abatement foam. According to the company, most of the affected devices are included in the first-generation DreamStation product line. According to Philips, the recently launched the DreamStation 2 will not have these risks since it does not have use the foam.
As information is still developing for the CPAP, BiPAP and ventilator devices, those injured can stay updated by revisiting our website. If you feel you may have been injured, contact us by using our contact form here. You can also give us a call at 404-419-9500.