Philips has issued a recall for select sleep apnea machines and ventilators over concerns that a foam component may disintegrate and be inhaled by the user possibly causing health issues including toxic and carcinogenic effects.
The products impacted by the recall include 3 million to 4 million specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAC) and mechanical ventilator devices. The company first warned of the issue in April 2021.
"The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates," the company said in a news release posted Monday. "To date, there have been no reports of death as a result of these issues. Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions."
Those who are using the impacted BiLevel PAP and CPAP devices are advised to discontinue use and consult a physician or durable medical equipment provider, while those who are using the mechanical ventilator devices should consult their physician before determining a course of action.
The company said it has already begun preparing to replace the sound abatement foam with new material, and will ship out new first-generation DreamStation products to impacted families following regulatory approval. The company’s DreamStation 2 CPAP is not impacted by the issue.