BiPAP A40 Ventilator

Official notice

30 Aug 2022

Last checked

30 Aug 2022

High riskACCC

An official ACCC notice concerns BiPAP A40 Ventilator. If the non-conforming material is present patients may be exposed to: 1. Chemical exposure due to off-gassing, creating a potential biosafety or toxicological hazard. 2. Sudden failure of the device causing a Ventilator Inoperative condition, which may result in asphyxia if not immediately identified and addressed by the care provider. Published 2022-08-30.

What to do now

Philips will replace all the affected devices, users will receive new A40 Pro units. For more details, see https://apps.TGA.gov.au/Prod/sara/arn-detail.aspx k=RC-2022-RN-01118-1 If you believe your product is affected and you have not received a letter from Philips, please contact Philips Sleep and Respiratory Care by phone on 1800 009 579.

Recall number

5a23c526-b9a7-43d4-aa8c-66f2215bfff9

Official notice

2022-08-30

The hazard

If the non-conforming material is present patients may be exposed to: 1. Chemical exposure due to off-gassing, creating a potential biosafety or toxicological hazard. 2. Sudden failure of the device causing a Ventilator Inoperative condition, which may result in asphyxia if not immediately identified and addressed by the care provider.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725010D13, V2887251114CB, V2887251771FD

Artg Numbers

200289

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Affected products

Product 1

BiPAP A40 Ventilator Serial numbers: V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725010D13, V2887251114CB and V2887251771FD ARTG 200289 (Philips Electronics Australia Ltd - Positive airway pressure unit, bi-level)

Risk / hazard

If the non-conforming material is present patients may be exposed to: 1. Chemical exposure due to off-gassing, creating a potential biosafety or toxicological hazard. 2. Sudden failure of the device causing a Ventilator Inoperative condition, which may result in asphyxia if not immediately identified and addressed by the care provider.

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

high

Recall details

Recall number

5a23c526-b9a7-43d4-aa8c-66f2215bfff9

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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