PRA number
Published date
Product description
DS Maref LX9 Sequential Pneumatic Compression Device
Serial numbers: 220112944 to 20117954 and 2026322 to 2032792
ARTG 206228
(Medi-Rent Pty Ltd - Compression unit, sequential)
Sequential Intermittent Pneumatic Compression (SIPC) therapy is the process of applying external pressure to the limbs to promote the circulation of blood and lymphatic fluid from the extremities of the body.
Reasons the product is recalled
A fault in the programming of the LX9 pumps, may cause users to experience higher pressure in the garments than set on the device.
The hazards to consumers
If the pressure in the garments becomes excessive for the user and exceeds the devices pressure specifications, this could result in an increased risk of health complications.
What consumers should do
Medi-Rent will update the programming on all pumps which have been programmed with software version 2020.11.01, which will correct the issue.
In the interim, consumers are advised to follow the instructions in the customer letter for use of the device until the reprogramming is complete.
For further information, contact Medi-Rent by phone on 1300 726 666.
Supplier
Traders who sold this product
Hospital and health services in ACT, NSW, SA, Qld, Vic and WA
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.