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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00094-1
Product Name/Description Valleylab FT10 energy platform

Item Code: VLFT10GEN

ARTG: 178604
(Medtronic Australasia Pty Ltd - Electrosurgical system generator, general-purpose)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/02/2018
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has been made aware that the power supply for the device fails when exposed to voltage spikes. Medtronic has developed a new power supply that will withstand the voltage irregularities experienced in the Australian market.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic will contact customers to arrange a service technician to install a new power supply in affected devices. In the interim, users should ensure the device is attached to a wall outlet and the wall switch is in the 'ON' position at all times until the unit has been upgraded.

This action has been closed out on 11/10/2019
Contact Information 1800 336 693 - Medtronic Customer Service Support