PRA number
2021/19121
Published date
Product description
Philips Respironics - Certain CPAP and Bi-Level PAP Devices
E30 (Emergency Use Authorization)
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
SystemOne (Q-Series)
DreamStation
DreamStation Go
Multiple Product Codes (See attached Product code list)
All devices manufactured before 26 April 2021
ARTGs: 133792, 209934, 235674, 257012, 257013, 295664, 285420, 327227, 335508
E30 (Emergency Use Authorization)
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
SystemOne (Q-Series)
DreamStation
DreamStation Go
Multiple Product Codes (See attached Product code list)
All devices manufactured before 26 April 2021
ARTGs: 133792, 209934, 235674, 257012, 257013, 295664, 285420, 327227, 335508
Reasons the product is recalled
The polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators may:
1. Degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and
2. Emit certain chemicals (volatile organic compounds or VOCs).
1. Degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and
2. Emit certain chemicals (volatile organic compounds or VOCs).
The hazards to consumers
Foam degradation:
The potential risks of particulate exposure include: irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic effects.
VOC emission:
The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
The potential risks of particulate exposure include: irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic effects.
VOC emission:
The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
What consumers should do
It is important that you register your device as soon as possible at the support website www.philips.com/src-update
Do not stop or alter your prescribed therapy; stopping treatment suddenly could have an immediate and detrimental effect on your health. Before making any changes to prescribed therapy, make an appointment with your physician or care provider to discuss alternative long term therapy options.
Philips will write to affected consumers. Users and carers should review the information provided in the customer letter about the ongoing use of impacted devices.
Philips will repair or replace the affected devices.
For more information see the TGA safety alert at https://www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-de…
For further information, please contact the Philips Support Hotline on 1800 009 579.
Do not stop or alter your prescribed therapy; stopping treatment suddenly could have an immediate and detrimental effect on your health. Before making any changes to prescribed therapy, make an appointment with your physician or care provider to discuss alternative long term therapy options.
Philips will write to affected consumers. Users and carers should review the information provided in the customer letter about the ongoing use of impacted devices.
Philips will repair or replace the affected devices.
For more information see the TGA safety alert at https://www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-de…
For further information, please contact the Philips Support Hotline on 1800 009 579.
Where the product was sold
Nationally
International
Dates available for sale
-
Recall advertisements and supporting documentation
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.