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 sleep therapy devices almost complete; ventilation ongoing
FDA feedback received on testing and analysis for sleep therapy devices1
Reached agreements to resolve economic loss, personal injury, and medical monitoring litigation in the US
Reached agreement with US government on a consent decree Back to market outside the US; servicing US market under agreed conditions part of the consent decree
Finalize recall and testing
DoJ investigation, other legal proceedings
Demonstrate compliance with the regulatory requirements and restore Respironics business
Gradually restore position
1. 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. Additional testing on the CPAP and BiPAP sleep therapy devices is ongoing in consultation with the FDA
For more information on the recall notification for customers, users and physicians, please click here.
Leandro Mazzoni Head of Investor Relations
Alexandra von Maltzan Deputy Head of Investor Relations
Dorin Danu Investor Relations Director
Shav Sharipov Investor Relations Director
Rashiq Muhaimen Investor Relations Manager - ESG
Monique van der Heiden Corporate Access Manager
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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