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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00398-1
Product Name/Description	BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion, turn-assist, flexible patient positioning capabilities and built-in scales for large patients) Model Number: 404000 Affected Serial Numbers: BKIK00570, BKIK00565 and BKIK00563 Supplied previously in Australia by KCI Medical Australia Pty Ltd under ARTG# 176118
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/05/2013
Responsible Entity	ARJO Hospital Equipment Pty Limited
Reason/Issue	There have been reports of patients inadvertently placing the system into a pseudo-exit position when using the hand control pendant.
Recall Action	Recall for Product Correction
Recall Action Instructions	Customers are requested to remove the hand pendant from use on all BariAir Therapy Systems. If removal of the hand pendant is not possible it is recommended that patient positioning is regularly inspected. A new hand pendant has been developed. ArjoHuntleigh will contact their customers to coordinate the replacement of the hand pendant.
Contact Information	08 9314 4117 - ArjoHuntleigh Quality and Regulatory Officer