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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00859-1
Product Name/Description	Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes) Model Numbers: OTV-S190, CV-190, 3DV-190, CLV-S190, CLV-190, UHI-4, UPD-3 & CV-170 ARTG Numbers: 120819, 120820, 194240, 211802, 219880 & 216644
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/08/2014
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	The power switch of the abovementioned models may become stuck after extended use and the following may occur: 1) When the power switch is stuck whilst the unit is ‘ON’, the unit cannot be turned ‘OFF’ using the power switch on the model. 2) When the power switch is stuck whilst the unit is ‘OFF’, the unit cannot be turned ‘ON’ using the power switch on the unit. This issue could result in a delay of diagnosis or treatment procedure as the device would no longer be operational a replacement device would be needed to complete treatment or diagnosis.
Recall Action	Recall for Product Correction
Recall Action Instructions	An Olympus Field Service Technician will replace the power switch on all the affected units. This action has been closed-out on 18/07/2016.
Contact Information	1300 132 992 - Olympus Australia