Philips is recalling breathing devices and ventilators due to foam that might degrade and become toxic, possibly causing cancer, the Dutch medical equipment maker said on Monday.
The recall involves specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices to address potential health risks related to polyester-based polyurethane sound abatement foam that is in the machines, Philips said in a news release.
Foam used to soften the sound made by the machines can deteriorate and project tiny particles and gases that can irritate airways, cause headaches and possibly be toxic or carry cancer risks, according to the company.
No deaths have been reported in connection with the recalled devices.
“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,” CEO Frans van Houten stated.
Philips has produced millions of devices using the foam, with a low complaint rate of 0.03% last year, the company reported.
Those using the ventilators to sustain life should not alter their prescribed therapy until they’ve talked to their physician, with others using bi-level PAP and CPAC devices should discontinue their use and talk to their doctor, the company said. Consumers can learn more here.
The company, one of the largest manufacturers of sleep apnea machines and ventilators, reported in quarterly earnings in late April that it had identified a quality issue with some sleep apnea and respiratory products, stating it was looking into the matter.