A recall notice for Philips Respironics - Certain CPAP and Bi-Level PAP Devices supplied by Philips Electronics Australia Ltd as the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators may:
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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
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Emit certain chemicals (volatile organic compounds or VOCs).
Philips Electronics Australia Ltd - Philips Respironics - Certain CPAP and Bi-Level PAP Devices
PRA No.
2021/19121
Date published
27 Jul 2021
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
Identifying features
Other
See attached Product code list
Product code list.pdf (24.46 KB)
What are the defects?
The polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators may:
-
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
-
Emit certain chemicals (volatile organic compounds or VOCs).
What are the hazards?
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.
What should consumers 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-dev…
For further information, please contact the Philips Support Hotline on 1800 009 579.
Supplier
Philips Electronics Australia Ltd
Where the product was sold
Nationally
International
Dates available for sale
- 30 July 2007 - 7 July 2021
Recall advertisements and supporting documentation
Recall advertisement.pdf (344.45 KB)
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.
Product category
