June 15, 2021 -- Dutch-based medical equipment maker Philips is recalling CPAP machines, ventilators, and other breathing devices because of concerns that sound-reducing foam on the devices can degrade and be inhaled by the users, causing possible health risks, including cancer, the company said in a news release.
Philips CEO Frans van Houten said between 3 million and 4 million would be recalled, according to Reuters.
Philips spokesman Steve Klink told Reuters about 80% of the affected devices were CPAP (continuous positive airway pressure) machines used by people with sleep apnea, with around two-thirds of Philips CPAP machine sales in the United States.
Ventilators make up the other 20%, the outlet reported, with some BiPAP (bi-level positive airway pressure) machines also recalled.
The company will send out updated operating instructions and repair and replace the foam, the company said. Regulatory agencies have been notified.
Philips has produced millions of devices that use the polyester-based polyurethane (PE-PUR) sound-reducing foam and determined degraded foam may be ingested by the user and that foam may release “certain chemicals,” the news release said.
But there have been no reports of death because of these problems.
If you use devices like ventilators to sustain life, you should keep using them until you’ve consulted with a medical care provider. But the company recommends not using the bi-level PAP or CPAP devices and says you should talk with your doctor.
The recently launched next-generation CPAP platform, DreamStation 2, is not included in the recall, Philips said
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” van Houten said in the news release.