We use cookies and other tools to enhance your experience on our website and to analyze our web traffic.
For more information about these cookies and the data collected, please refer to our Privacy Policy.

Philips issues a recall on a number of CPAP/BIPAP machine

93 posts
Was this reply useful? Learn more...
   
[-]
SusanR +0 points · about 2 months ago Original Poster Researcher

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

DreamStation
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

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)

32 posts
Was this reply useful? Learn more...
   
[-]
MarkHanson +0 points · about 2 months ago

thank you !

93 posts
Was this reply useful? Learn more...
   
[-]
SusanR +0 points · about 1 month ago Original Poster Researcher

Additional Advice from the American Thoracic Society: "For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant pulmonary, cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that they not stop their prescribed therapy until first discussing with their physician. For other patients, Philips recommends the device should be discontinued and the physician/DME provider be contacted to determine the most appropriate option for continued treatment. If your physician determines that you should continue using this device, consider use of in-line bacterial filter. Consult your Instructions for Use for guidance on installation."

1 post
Was this reply useful? Learn more...
   
[-]
aaronjay +0 points · about 1 month ago

Thank you for this valuable information from the American Thoracic Society. Do you by any chance have a link online for that statement from them? Much appreciated Aaron

PS, never mind. I found it https://www.thoracic.org/patients/patient-resources/recommendations-for-sleep-and-critical-care-medicine-professionals-regarding-philips-recall-notice.php

Please be advised that these posts may contain sensitive material or unsolicited medical advice. MyApnea does not endorse the content of these posts. The information provided on this site is not intended nor recommended as a substitute for advice from a health care professional who has evaluated you.