Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

3,000,000

repair kits and replacement devices produced to date globally

1,400,000

devices shipped in the US

*Market specific numbers as of July 22, 2022 and will be updated monthly.

Information for clinicians, all in one place

 

Patient safety is our top priority


In June 2021, after discovering a potential health risk related to the foam used for sound deafening in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside the US)/voluntary recall notification (US only).


We are committed to supporting you and the clinical community through the full remediation process and have developed a range of resources to help you care for your patients that can be accessed in the links below.


We want to make sure you receive timely information on both the measures we take and the progress we are making. We update this page regularly with details of testing reports and clinical studies on the potential harm associated with the foam or Volatile Organic Compounds (VOCs), where we are in the remediation process, as well as summaries of the information your patients are receiving from us, so please check it regularly.


If you have any questions, or would like more information on the content provided, please reach out to your Philips sales representative.


We thank you for your patience as we work to restore your trust.

We have asked your patients to take the following steps:

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Learn about the voluntary recall and register their affected device

Support line 877-907-7508

Iicon check status

Check their replacement device status

Registered patients can also enter prioritization information. This information helps patients with the greatest needs receive their replacement device sooner.

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Learn more about and set up their replacement device

Icon for returning your device

Return their affected device

When your patients receive their replacement device, it will include instructions on how to return their original device and how to set up their replacement. 

DreamStation 2

Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device.

The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced.

Frans van Houten and Roy Jakobs

Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice

Frans van Houten and Roy Jakobs

Technical Project Manager Jan Bennik speaks about the test and research program

News and updates    

Important updates for clinicians

All Clinician updates    

Questions and answers

The following products listed are affected by the recall notification / field safety notice:

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 Emergency Use Authorization

E30

(Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ASV

DreamStation ASV

Also known as ​DreamStation BiPAP autoSV​

DreamStation ST, AVAPS

DreamStation ST, AVAPS

Also known as​ DreamStation BiPAP AVAPS, ​DreamStation BiPAP S/T

SystemOne ASV4

SystemOne ASV4

Also known as​ System One BiPAP autoSV, ​System One BiPAP autoSV Advanced​

C Series ST, AVAPS

C Series S/T, AVAPS

Also known as​ System One BiPAP AVAPS (C-Series), ​System One BiPAP S/T (C-Series)​​​

OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

50 Series CPAP, ASV

System One 50 series

CPAPs, Auto CPAP, BiPAPs​

60 Series CPAP, ASV

System One 60 series

CPAPs, Auto CPAP, BiPAPs​

DreamStation CPAP

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation Go

DreamStation GO CPAP, APAP, Auto CPAP

Dorma 400, 500

Dorma 400, 500 ​CPAP, Auto CPAP

(not marketed in US)​

If your device is affected...

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator

Trilogy 100

Trilogy 100 Ventilator

Trilogy 200

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

(not marketed in US)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30

A-Series BiPAP Hybrid A30

Also known as ​BiPAP Hybrid A30​Ventilator​ (A-Series)​
(not marketed in US)

A-Series BiPAP V30 Auto Ventilator

A-Series BiPAP V30 Auto Ventilator

Also known as​ BiPAP V30 Auto​ Ventilator ​(A-Series)

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-Series BiPAP A40

Also known as ​BiPAP A40​ Ventilator ​(A-Series)​
(not marketed in US)​​

A-Series BiPAP A30

A-Series BiPAP A30

Also known as ​BiPAP A30​ Ventilator​ (A-Series)​
(not marketed in US)​​

If your device is affected...

What products are not affected and why?

 

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.

  • Trilogy Evo

  • M-Series

  • Trilogy Evo OBM

  • Trilogy EV300

  • Trilogy 202

  • A-Series Pro and EFL

  • DreamStation 2

  • Omnilab (original based on Harmony 2)

  • Dorma 100, Dorma 200, & REMStar SE

  • V60 Ventilator

  • V60 Plus Ventilator

  • V680 Ventilator

  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

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