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

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November 14, 2021

Amsterdam, the Netherlands – On June 14, 2021, Royal Philips ’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification* for sure sleep and respiratory care merchandise to handle recognized potential well being dangers associated to the polyester-based polyurethane (PE-PUR) sound abatement foam in these gadgets. Following the substantial ramp-up of its manufacturing, service, and restore capability, the restore and alternative program within the US and several other different markets is beneath manner.

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As anticipated, the US Meals and Drug Administration (FDA) lately carried out an inspection of a Philips Respironics manufacturing facility in reference to the recall. On November 12, 2021, the FDA revealed an inventory of the observations it offered to Philips Respironics. In accordance with regular follow, Philips Respironics will submit its response to the inspectional findings for assessment by the FDA. Importantly, an FDA investigator’s record of inspection observations doesn’t represent a remaining FDA dedication of whether or not any situation is in violation of the Federal Meals, Drug, and Beauty Act or any of its implementing laws. Moreover, the FDA has not modified its advice to sufferers and healthcare suppliers in relation to affected gadgets. 

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“In reference to the voluntary recall notification in June of this yr, the FDA has lately carried out an inspection of a Philips Respironics manufacturing facility within the US,” stated Frans van Houten, CEO of Royal Philips. “We’ll work intently with the FDA to make clear and comply with up on the inspectional findings and its latest requests associated to complete testing. Till we’ve concluded these discussions, we aren’t in a position to publicly present additional particulars on these responses. We stay absolutely dedicated to supporting the group of sufferers who depend on the affected gadgets, and the physicians and prospects who’re devoted to assembly affected person wants.”

Since June 2021, Philips Respironics and licensed testing laboratories have been conducting a complete check and analysis program on the PE-PUR foam to raised assess and scope potential affected person well being dangers, with help from appropriately certified third-party specialists. Philips Respironics plans to make extra information out there to the related competent authorities as quickly as doable after finishing the evaluation of the above talked about analysis and checks, which is anticipated to happen within the fourth quarter.

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Individually, Philips Respironics has carried out testing to help the brand new silicone alternative foam. Silicone foam testing offered by Philips Respironics to the FDA on gadgets approved for advertising within the US had demonstrated acceptable outcomes. Philips Respironics continues to coordinate with the FDA and different competent authorities on its testing.

An FAQ is obtainable here .

* Voluntary recall notification within the US/discipline security discover exterior the US

For additional data, please contact:

Steve Klink
Philips World Press Workplace
Tel.: +31 6 10888824
E-mail: steve.klink@philips.com

Derya Guzel
Philips Investor Relations
Tel.: +31 20 59 77055
E-mail: derya.guzel@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a number one well being know-how firm targeted on bettering individuals’s well being and well-being, and enabling higher outcomes throughout the well being continuum – from wholesome dwelling and prevention, to analysis, remedy and residential care. Philips leverages superior know-how and deep scientific and client insights to ship built-in options. Headquartered within the Netherlands, the corporate is a frontrunner in diagnostic imaging, image-guided remedy, affected person monitoring and well being informatics, in addition to in client well being and residential care. Philips generated 2020 gross sales of EUR 17.3 billion and employs roughly 78,000 staff with gross sales and providers in additional than 100 nations. Information about Philips will be discovered at www.philips.com/newscenter .

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