The recall notification (U.S. only) / field safety notice (International Markets) 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 recall notification (U.S. only) / field safety notice (International Markets) include:
E30
(Emergency Use Authorization)
DreamStation
ASV
DreamStation
ST, AVAPS
SystemOne
ASV4
C Series
ASV, S/T, AVAPS
OmniLab Advanced Plus
In-Lab Titration Device
SystemOne
(Q series)
DreamStation
CPAP, Auto CPAP, BiPAP
DreamStation GO
CPAP, APAP
Dorma 400, 500
CPAP
REMStar SE Auto
CPAP
Trilogy 100
Ventilator
Trilogy 200
Ventilator
Garbin Plus, Aeris, LifeVent
Ventilator
A-Series BiPAP Hybrid A30
(not marketed in US)
A-Series BiPAP V30 Auto
Ventilator
A-Series BiPAP A40
(not marketed in US)
A-Series BiPAP A30
(not marketed in US)