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.
Supplier
Traders who sold this product
Hospitals and distributors
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.