Amsterdam, the Netherlands – On June 14, 2021, Royal Philips’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Since then, together with certified testing laboratories and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs). Philips Respironics is now providing an update on part of this test and research program. Specifically, this update covers the test results and assessment to date of the VOC emissions of the first-generation DreamStation devices. The first-generation DreamStation devices represent the majority of the registered affected devices. Additional testing is ongoing.**
Review of this assessment by an outside medical panel and Philips Respironics has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.
The update on these findings is intended to inform healthcare providers of the most recent data, but the overall guidance for physicians and patients in the recall notification remains unchanged at this time.