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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00722-1
Product Name/Description	aView 2 Advance Catalogue number: 405011000 Version number: 054, 055, 056, 058, 059 Serial number: A220100955 ARTG 405973 (AMBU Australia Pty Ltd - Endoscopic video image processor) ARTG 337704 (AMBU Australia Pty Ltd - Endoscopic video image display monitor)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/08/2023
Responsible Entity	AMBU Australia Pty Ltd
Reason/Issue	Ambu has received information where an Ambu aView 2 Advance has been dropped on the floor, short-circuited, and thereafter combusted. No patient or staff member was harmed, and the incident is regarded as an exceptionally rare case. No complaints have been received in which a patient or staff member has been reported to have been harmed as a result of any such incident.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers are advised that they should check their version number, manufacturing date and serial number of their devices to identify if they have a potentially impacted product. If the device is an earlier configuration of the aView 2 Advance, then customers are to become familiar with the addition to the IFU insert provided. The IFU addition is a safety statement advising of the issues that may arise due to the lithium ion battery as a result of damage caused to the device. This action has been closed out on 15/11/2023.
Contact Information	02) 9998 1000 / 1300 233 118 - Brett Wesney