On June 14, 2021, Royal Philips’ subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. Philips Respironics has also 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).
Remediation of >99% of sleep therapy devices complete1; ventilators ongoing
FDA feedback received on testing and analysis for sleep therapy devices2
Reached agreement to resolve economic loss class action in the US
Philips Respironics reaches agreement with US government on a consent decree creating a clear path forward 483 remediation in progress Started serving new patients with sleep therapy devices outside the US
Finalize recall and testing
Manage litigation, DoJ investigation
Comply with terms of consent decree
Gradually restore position
1. Over 99% of the sleep therapy device registrations that are complete and actionable have been remediated. 2. Following ongoing communications with the FDA, Philips Respironics has agreed to implement additional testing to supplement current test data on PE-PUR foam. The FDA stated that current testing is extensive and conducted with independent parties and expressed no concerns with its validity or objectivity. Philips Respironics is in discussions with the FDA on the details of further testing.
For more information on the recall notification for customers, users and physicians, please click here.
Leandro Mazzoni Head of Investor Relations
Dorin Danu Investor Relations Director
Rashiq Muhaimen Investor Relations Manager – ESG related topics
Monique Corporate Access Manager
van der Heiden
Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world
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