Millions of sleep apnea machines and ventilators were recalled because users can breathe tiny particles of a toxic cancer-causing foam that was used as sound insulation.
The toxic foam is used to dampen the sound of the machine. The problem is that it may disintegrate and users may inhale small particles. Gases released by the disintegrating foam are also toxic.
Philips said no one has died due to foam degradation, but some patients may have been harmed by breathing foam particles. The risks include “headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects,” according to the company.
There were no reports of patients who were harmed by toxic gases, but the “risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects,” Philips explained.
The recall involves specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices.
Philips said about 80% of the recalled devices are machines that are used to treat people with sleep apnea, also known as Continuous Positive Airway Pressure (CPAP) machines. The other 20% of the devices are ventilators.
The company said it was working with health officials to find a safe replacement for the foam.
In the meantime, Philips is warning against using certain unapproved cleaning methods, such as ozone, which may worsen the foam degradation. High heat and humidity environments may also contribute to foam degradation.