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).

Repair and Replacement, Testing and Program Management
Repair and Replacement, Testing and Program Management
Comprehensive patient and customer outreach program; clinical information package addressing physician questions

Estimated 5.5 million devices eligible for repair/replace. DreamStation 1 and U.S. market make up the significant majority of the installed base

Anticipate a 50/50 mix (repair/replace)

Provision of ~EUR 720 million taken in 2021 and EUR 65 million in Q1 2022 related to the cost to repair/replace affected systems; further EUR 100 million provision recorded in Q1 2022 for possible higher cost of execution and to ensure the speed of the program

Because of the prioritization of the repair and replace program, not taking new orders for sleep therapy systems, while masks and other consumables continue to be sold

Previous estimate for number of expected units to be remediated was based on registrations up to Q4 2021 and regression model estimate for following quarters

Increase of registrations in the US in February 2022 lead to increase in the total expected units to be remediated by 300,000

Testing

Philips Respironics is conducting a comprehensive test and research program to better assess and scope potential patient health risks:

Volatile Organic Compounds (VOCs): test results to date (published here on December 23, 2021) for DreamStation1 devices indicated that VOCs are within the limits of safe exposure specified in applicable safety standard (ISO 18562)

Particulates: further testing and analyses are on-going

Impact of ozone cleaning: initial testing results indicate PE-PUR foam degradation is accelerated by repeated exposure to ozone. Further testing is on-going

Silicone foam: further testing on-going to further substantiate the safety of the silicone foam

Previous testing demonstrated acceptable results in accordance with applicable standards

Certified labs are conducting the tests with FDA oversight

Clinical information

Click on the links below for additional clinical details on the issue and other information.

Click here to get more information for physicians and providers

Click here to get more information on Volatile Organic Compounds (VOCs) test results
Cooperation and Engagement with Regulators
Cooperation and Engagement with Regulators
Philips Respironics continues to work closely with the FDA and other regulators and relevant competent authorities globally

FDA Form 483 issued on November 12, 2021, following an inspection of Philips Respironics’ site in the U.S.

Philips Respironics has submitted a comprehensive response and detailed action plan with ongoing engagement with the FDA; Philips Respironics will first work through the process with the FDA and other regulators before commenting in detail

The Form 483 did not change the FDA’s recommendation to patients or care providers related to the use of the devices, nor the authorization to execute the repair and replacement program

FDA 518(a) order issued on March 10, 2022, regarding recall outreach

Philips Respironics is complying with the FDA’s order

Philips Respironics and the FDA are fully aligned on the need to increase awareness of the recall and give healthcare providers, consumers and patients access to timely information
Litigation Update
Litigation Update
Civil complaints filed in several jurisdictions alleging economic loss, personal injury and the need for medical monitoring

As of March 2022, approximately 185 personal injury lawsuits filed in the U.S. and over 100 class actions that we expect to be consolidated into 2 class actions over the summer of 2022

In October 2021, cases were consolidated in multidistrict litigation in Pennsylvania; case management has been largely procedural

Outside the U.S., Philips or its affiliates are also defendants in litigation in Australia, Canada, Chile, and Israel, as well as in smaller or individual actions in other countries

Philips is also defending a securities class action case and a lawsuit by SoClean in the U.S.; Philips has already moved to dismiss the securities class action and intends to move to dismiss the SoClean case

All litigation is in preliminary procedural stages – the outcome and potential cost of the lawsuits cannot currently be determined; the company has not taken any provision related to litigation to date

Strong and experienced legal defense team in place

Frequently Asked Questions

Respironics field action - FAQ - 25th of April 2022 (182.0KB)

More information

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

News

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Contact Investor Relations

Leandro Mazzoni

Head of Investor Relations

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Derya Guzel

Investor Relations Manager

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Monique
van der Heiden

Executive Assistant

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For any other matters not directly related to Investor Relations, please visit our company contacts page.

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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Respironics field action

Testing

Philips Respironics is conducting a comprehensive test and research program to better assess and scope potential patient health risks:

Clinical information

Frequently Asked Questions

More information

News

You may also find the following articles interesting

Philips Respironics provides update for the US on ongoing CPAP, BiPAP and Mechanical Ventilator field action

Philips provides update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification*

Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification

Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification

Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices

Contact Investor Relations