What devices are affected by the field safety notification*?
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, Minimum Ventilatory Support, Facility Use
(Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting
ASV
ST, AVAPS
ASV4
AVAPS, ST, ASV
In-Lab Titration Device
Noncontinuous Ventilator
(Q series)
CPAP, Auto CPAP, BiPAP
CPAP, APAP
CPAP
CPAP
BiPAP
Mechanical Ventilators
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers
Continuous Ventilator
Ventilator
Ventilator
Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
(not marketed in the US)
Ventilator
Continuous Ventilator, Non-life Supporting
(not marketed in US)
(not marketed in US)
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.
Products not affected by this field safety notification* include:
- 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.
* In Australia this is an Urgent Product Defect Correction and in New Zealand this is a Recall for Product Correction