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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01141-1
Product Name/Description	ENDOEYE Video Telescope ENDOEYE 10mm 0 degrees Part #: WA50040A S/N: 622642, 622770, 622774, 622776, 623616, 623617, 623618, 623620, 624087, 624088 ENDOEYE 10mm 30 degrees Part #: WA50042A S/N: 622506, 622529, 622530, 622531, 622532, 622533, 622781, 623665, 623667, 623684, 624075, 624094, 624619, 624627 ENDOEYE devices repaired with affected spare part Part #: WA50040A or WA500422 S/N: 616960, 616963, 617144, 617801, 619863 ARTG Number: 121101
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	23/11/2015
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	The backup mechanism designed to detect and identify a failed temperature sensor is not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. Although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the ENDOEYE distal end could result in patient or user injury.
Recall Action	Recall for Product Correction
Recall Action Instructions	Olympus is advising the customers to inspect stock and quarantine the affected units prior to their return to the sponsor. Upon receiving the affected units, Olympus will perform a short term correction by disabling the "fog-free" function and return the corrected units back to the customers for routine use. A final permanent fix involving a hardware upgrade will restore full functionality of the device is expected to be performed in 2016.
Contact Information	1300 657 699 - Olympus Customer Service