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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00824-3
Product Name/Description Halo Flex Energy Generators (Endotherapy electrosurgical unit)

Model Number: 1190A-230A
All serial numbers
ARTG Number: 140684
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/08/2012
Responsible Entity Covidien Pty Ltd
Reason/Issue Covidien has received reports related to a generator malfunction where the HALOFLEX Energy Generator fails to enter “standby mode” when initially powered-on. The generator became stuck in the self-test mode upon initial power-on, did not enter standby mode, and therefore could not be used for patient care.
Recall Action Recall for Product Correction
Recall Action Instructions The customer letter provides temporary work around instructions. Covidien is developing a software revision, which will be available by the end of August 2012 that will prevent the malfunction from recurring.
Contact Information 1800 350 702 - Technical Services