Dutch medical equipment company Philips has ordered global recall of some breathing devices and ventilators because of a foam part might degrade and become toxic, potentially causing cancer.
The company said that the foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways. Gases released by the degrading foam may also be toxic or carry cancer risks, it added.
Philips Chief Executive Frans van Houten said the company was one of the largest makers of sleep apnea machines and ventilators. Between 3 million and 4 million would be targeted in the recall, he said, according to Reuters.
“We are going to put all our capacity to focus entirely on replacing and repairing these units,” Houten added.
Company spokesman Steve Klink said about 80% of the affected devices were machines used to help people with sleep apnea, known as Continuous Positive Airway Pressure (CPAP) machines. The users of those machines were advised to halt usage.
Philips said that doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks.
“Philips has received reports of possible patient impact due to foam degradation. To date, there have been no reports of death as a result of these issues,” the company said in a statement.
Philips added that it was working with health authorities on a safe replacement for the foam, but that it must first clear testing and regulatory hurdles.
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