www.fdanews.com/articles/203184-philips-recalls-respiratory-devices-with-foam-component-problem
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Philips Recalls Respiratory Devices with Foam Component Problem
June 16, 2021
Philips has announced a recall of 3.5 million ventilation devices used to treat sleep apnea because of potential health risks linked to a foam component.
In some models of its bi-level positive airway pressure, continuous positive airway pressure and mechanical ventilator devices, the polyurethane sound-abatement foam could degrade into particles that have toxic and carcinogenic effects, the company said.
Philips is taking corrective actions, including issuing updated usage instructions and launching a repair and replacement program for the affected devices.