Royal Philips NV recalled about 3.5 million ventilation devices used to treat sleep apnea and increased its cost estimate for addressing a defect that might potentially cause cancer.
The company said some of its ventilators use sound-abatement foam that might degrade into particles that could be ingested or inhaled and potentially have toxic and carcinogenic effects.
The recall is a setback for Philips as it shifts to focus entirely on healthcare products. The company reached an agreement earlier this year to sell its domestic appliances business to private equity firm Hillhouse Capital and first flagged the quality issue with certain sleep and respiratory-care products in April.
Exposure to the polyester-based polyurethane foam that can enter patients’ airways can cause headache, irritation, inflammation and respiratory issues, Philips said.
The company issued a recall notification only for the US and announced a field safety notice for the rest of the world.
Philips doubled its provision for expected costs related to the issue to 500 million euros (US$605 million).
Sleep apnea is a sleep disorder in which breathing stops and starts, causing fatigue and leading to longer-term health risks. Philips has a range of ventilator products aimed at improving sleep patterns, many sold under the DreamStation product family.
Philips said it was working with regulators on a repair and replacement program.
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