Philips Respironics - Certain CPAP and Bi-Level PAP Devices

Official notice

27 Jul 2021

Last checked

27 Jul 2021

Low riskACCC

An official ACCC notice concerns Philips Respironics - Certain CPAP and Bi-Level PAP Devices. 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. Published 2021-07-27.

What to do now

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-devices-and-mechanical-ventilators For further information, please contact the Philips Support Hotline on 1800 009 579.

Recall number

c520c3d8-2091-483d-99ee-4bca518e8b23

Official notice

2021-07-27

The hazard

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.

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Affected products

Product 1

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

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

low

Recall details

Recall number

c520c3d8-2091-483d-99ee-4bca518e8b23

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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