Respironics field action

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). 

Resolving the recall for patients remains our highest priority


Finalize recall of sleep therapy devices

Agree details of further testing with FDA1

Manage litigation, DoJ investigation

483 remediation and clarity on proposed Consent Decree

YTD 2023


Remediation of >99% of sleep therapy devices complete2; ventilators ongoing


FDA feedback received on testing and analysis for sleep therapy devices1

Reached agreement to resolve economic loss class action in the US

483 remediation in progress

Started serving new patients with sleep therapy devices outside the US


Finalize recall and testing

Manage litigation, DoJ investigation

Manage impact of proposed Consent Decree

Gradually restore position

Taking the learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips

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. Philips Respironics is in discussions with the FDA on the details of further testing

2. Over 99% of the sleep therapy device registrations that are complete and actionable have been remediated

More information

For more information on the recall notification for customers, users and physicians, please click here.


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*    This is a recall notification for the US only, and a field safety notice for the rest of the world

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