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Created page with "---- ===Timeline=== ====April 26, 2021==== https://www.usa.philips.com/healthcare/e/sleep/communications/src-update Philips advised of potential health risks related to sound..."
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===Timeline===
====April 26, 2021====
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.<br />
Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.
====June 14, 2021====
https://www.apneaboard.com/PR-Recall.pdf
As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.
===Impacted Devices===
All Devices manufactured before 26 April 2021,
All serial numbers
Continuous Ventilator, Minimum Ventilatory Support, Facility Use E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
Noncontinuous Ventilator SystemOne (Q-Series)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto
{| class="wikitable"
|-
! All Devices manufactured before 26 April 2021,
All serial numbers
|-
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use|| E30 (Emergency Use Authorization)
|-
| Continuous Ventilator, Non-life Supporting||
*DreamStation ASV
*DreamStation ST, AVAPS
*SystemOne ASV4
*C-Series ASV
*C-Series S/T and AVAPS
*OmniLab Advanced+
|-
| Noncontinuous Ventilator||
*SystemOne (Q-Series)
*DreamStation
*DreamStation Go
*Dorma 400
*Dorma 500
*REMstar SE Auto
|}
----
===Timeline===
====April 26, 2021====
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.<br />
Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.
====June 14, 2021====
https://www.apneaboard.com/PR-Recall.pdf
As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.
===Impacted Devices===
All Devices manufactured before 26 April 2021,
All serial numbers
Continuous Ventilator, Minimum Ventilatory Support, Facility Use E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
Noncontinuous Ventilator SystemOne (Q-Series)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto
{| class="wikitable"
|-
! All Devices manufactured before 26 April 2021,
All serial numbers
|-
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use|| E30 (Emergency Use Authorization)
|-
| Continuous Ventilator, Non-life Supporting||
*DreamStation ASV
*DreamStation ST, AVAPS
*SystemOne ASV4
*C-Series ASV
*C-Series S/T and AVAPS
*OmniLab Advanced+
|-
| Noncontinuous Ventilator||
*SystemOne (Q-Series)
*DreamStation
*DreamStation Go
*Dorma 400
*Dorma 500
*REMstar SE Auto
|}
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