A recall notice for Certain Ventilator Devices supplied by Philips Electronics Australia Ltd as the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips 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 Ventilator Devices
PRA No.
2021/19120
Date published
27 Jul 2021
Product description
Philips Respironics - Certain Ventilator Devices
Trilogy 100, Trilogy 200 and BiPAP A30/A40 Series Device Models
Product codes: 1076581, 1076582, 1076583, 1111145, 1111171, AU1054096
All devices manufactured before 26 April 2021
ARTGs 133794, 200289, 159490
What are the defects?
The polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips 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 ventilator therapy. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required.
Phillips 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
- 1 April 2010 - 7 July 2021
Recall advertisements and supporting documentation
Recall advertisement.pdf (346.6 KB)
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.
Product category
