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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00835-1
Product Name/Description Fabius Anaesthesia Machine

Supplied between February to July 2013
Serial Number: ASEC-0203
ARTG Number: 104223
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/08/2013
Responsible Entity Draeger Medical Australia Pty Ltd
Reason/Issue Some units did not pass the high voltage test during the final checking of the Fabius by the manufacturer. Investigations carried out revealed that on some power supply units, the required minimum clearance between an electrical component and the unit housing was not maintained. Under the influence of mechanical forces (e.g., movement of the device), this may result in small bypass currents flowing in the interior of the unit which in extreme cases cause failure of the automatic ventilation function of the device. When such faults occur, the standard required manual ventilation is possible, an acoustic alarm is generated and the indicators on the device flash.
Recall Action Recall for Product Correction
Recall Action Instructions As an interim measure, Draeger Medical is advising users to switch over to manual ventilation mode should users experience a failure of the automatic ventilation function. The power supply units will be replaced as a permanent correction.
Contact Information 1800 800 327 - Draeger Medical Australia Customer Service