Invacare Australia Pty Ltd — Invacare Perfecto2 V Oxygen Concentrator

PRA number


Published date

Product description

Invacare Perfecto2 V Oxygen Concentrator

Product Model: IRC5PO2VAWL2

Serial numbers: 18BF007341 to 181F024339

ARTG: 162637

(Invacare Australia Pty Ltd - Oxygen concentrators)

Reasons the product is recalled

The sound abatement washer may break down resulting in metal on metal wear inside the Pressure Equalisation (PE) valve.

This may lead to high temperatures and overheating, separation of the shroud from the device, and loud noise, and can result in a fire that will shut down the device.

The hazards to consumers

If the device shuts down this can cause hypoxemia (low oxygen in the blood) from "loss of use". There is an increased risk of fire, which may result in serious injury and property damage.

What consumers should do

Consumers should check the model and serial number of their machine to see if their device is affected. Invacare Australia will contact affected users in writing with instructions on how to to make arrangements to replace the PE valve assembly. The replacement of the PE valve assembly will be done within 6 months.

In the interim, consumers should continue to use the device in accordance with its labelling/user manual.

Labelling that accompanies the device instructs the user to always have a backup source of oxygen readily available.

For further information, consumers can contact Invacare Australia on 1800 460 460.

Traders who sold this product

Hospitals and distributors

Where the product was sold

New South Wales
South Australia
Western Australia

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

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