Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

Information for patients, all in one place

 

Your health and well-being remain our main priority and we are committed to completing the remediation of all affected devices. To ensure replacement devices get to those who need them, we have increased our production capacity to ensure we have CPAP and BiPAP devices available to distribute to patients.


We know there is still more to be done. If you have questions about the remediation process or need additional support once you have received your replacement device, please visit our updated Contact and Support page.

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If you registered an affected device and are still waiting for your replacement, it is likely because we need important information or consent from you. Without this information, we are unable to ship your replacement device. Depending on your affected registered device, you may have alternative options.  

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Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

May 2023 update on completed testing for home sleep therapy devices shows no appreciable harm to patients

 

The tests, conducted together with five independent, certified testing laboratories and assessed by third- party qualified experts and Philips Respironics, as well as an external panel of experts, have now been completed and risk assessments evaluated for all home sleep therapy devices.

News and updates    

All Patient 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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