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

2023

Finalize recall and testing

Manage litigation, DoJ investigation

483 remediation and clarity on proposed Consent Decree

H1 2023

line

~99% of recall units produced; >4.5M units1 w/ patients and care providers​

 

Completed all testing and analysis for DS1, DS Go and System One devices 

Provision related to anticipated resolution of the economic loss class action in the US

483 remediation in progress

2023-2025

Manage impact of proposed Consent Decree

Manage litigation, DoJ investigation

Gradually restore position

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


1. New replacement devices and repair kits required for the remediation of the total currently registered affected devices.

More information

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

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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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