What devices are affected by the field safety notification*?

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation
CPAP, Auto CPAP, BiPAP

DreamStation BiPAP

DreamStation
BiPAP

DreamStation ASV

DreamStation
ASV

DreamStation GO CPAP, APAP

DreamStation GO
CPAP,APAP

OmniLab Advanced Plus In-Lab Titration Device

OmniLab Advanced Plus
In-Lab Titration Device

System One 50 Series:  CPAP, Auto CPAP, BiPAP, ASV, ASV4

SystemOne
ASV4

System One 60 Series:  CPAP, Auto CPAP, BiPAP, ASV, ASV4

SystemOne
(Q series)

Dorma 400, 500 CPAP

Dorma 400, 500
CPAP

Noncontinuous Ventilator

DreamStation ST

DreamStation
ST, AVAPS

C Series AVAPS, ST, ASV

C Series
AVAPS, ST, ASV

A-Series 40/30 Ventilator, BiPAP, BiPAP Hybrid A30

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

Trilogy 100 Ventilator

Trilogy 100
Ventilator

Trilogy 200 Ventilator

Trilogy 200
Ventilator

V30 Ventilator

A-Series BiPAP V30 Auto
Ventilator

E30 Ventilator

E30
(Emergency Use Authorization)

What products are not affected and why?

  • Trilogy Evo

  • Trilogy Evo OBM

  • Trilogy EV300

  • Trilogy 202

  • BiPAP A40 EFL

  • BiPAP A40 Pro

  • M-Series

  • DreamStation 2

  • Omnilab (original based on Harmony 2)

  • Dorma 100, Dorma 200, & REMStar SE

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

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.

Products not affected by this field safety notification* include:

The field safety notification provides customers with information on how to identify affected products.


Additionally, the device Instructions for Use provide product identification information to assist with this activity.


Products affected by this field safety notification include:

CPAP and BiLevel PAP Devices

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

Continuous Ventilator, Non-life Supporting

REMStar SE Auto CPAP

REMStar SE Auto
CPAP

Mechanical Ventilators

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

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent
Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series 40/30 Ventilator, BiPAP, BiPAP Hybrid A30

A-Series BiPAP A30
(not marketed in US)

A-Series 40/30 Ventilator, BiPAP, BiPAP Hybrid A30

A-Series BiPAP A40
(not marketed in US)

Continuous Ventilator, Non-life Supporting

Continuous Ventilator

* In Australia this is an Urgent Product Defect Correction and in New Zealand this is a Recall for Product Correction