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Joined Oct 2014
Joined Oct 2014

Press release: https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.html

Recall FAQ: https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-faqs-for-dme-hcp.pdf.pdf

PHILIPS PAP USERS: Please review the following information regarding a voluntary recall for certain PAP machines due to safety concerns regarding the sound reducing foam used on a number of devices.

The following message was distributed by Philips today:

"Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, Bi-Level PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life. For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update."

Philips advises for patients using BiLevel PAP and CPAP devices:

"Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment."

Sleep clinics are now putting in place procedures for replacing equipment-- many patients using the equipment so affected will want to contact their physician or DME to discuss this. The PAP devices so affected are listed on the Philips web site and include (check with your DME with any questions):

CPAP and BiLevel PAP Devices All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator, Non-life Supporting DreamStation ASV

ASV DreamStation AVAPS

DreamStation ST, AVAPS 60 Series CPAP, ASV

SystemOne ASV4 C Series AVAPS/ST

C Series ASV, S/T, AVAPS OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus In-Lab Titration Device

Non-continuous Ventilator 60 Series CPAP, ASV

SystemOne (Q series) DreamStation CPAP

DreamStation CPAP, Auto CPAP, BiPAP DreamStation Go

DreamStation GO CPAP, APAP Dorma 400, 500

Dorma 400, 500 CPAP REMStar SE Auto CPAP


Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use A 40/30

A-Series BiPAP Hybrid A30 (not marketed in US) V30

A-Series BiPAP V30 Auto Ventilator

Continuous Ventilator, Non-life Supporting A 40/30

A-Series BiPAP A40 (not marketed in US) A 40/30

A-Series BiPAP A30 (not marketed in US)