What devices are affected by the field safety notification*?
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
DreamStation
CPAP, Auto CPAP, BiPAP
DreamStation
BiPAP
DreamStation
ASV
DreamStation GO
CPAP,APAP
OmniLab Advanced Plus
In-Lab Titration Device
SystemOne
ASV4
SystemOne
(Q series)
Dorma 400, 500
CPAP
Noncontinuous Ventilator
DreamStation
ST, AVAPS
C Series
AVAPS, ST, ASV
A-Series BiPAP Hybrid A30
(not marketed in the US)
Trilogy 100
Ventilator
Trilogy 200
Ventilator
A-Series BiPAP V30 Auto
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
Mechanical Ventilators
All Affected Devices Manufactured Before 26 April, 2021, All Device Serial Numbers
Garbin Plus, Aeris, LifeVent
Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP A30
(not marketed in US)
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