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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01066-1
Product Name/Description WATO EX-65 and A-Series (A5/A7) anaesthesia machines

Multiple Serial Numbers

ARTG Number: 158607
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/08/2017
Responsible Entity Mindray Medical Australia Pty Ltd
Reason/Issue Mindray has identified a potential issue related to Electrically Erasable Programmable Read-Only Memory (EEPROM) which will only occur if the system’s total number of write cycles to a particular range of memory locations has exceeded the life specification of the EEPROM. The issue will only manifest at start up or at the end of a case; it will not occur during a case. There are no adverse effects on the patient.
To date, there have been no reports of injuries associated with this issue
Recall Action Recall for Product Correction
Recall Action Instructions The manufacturer recommeds cessation of the use of machines which have experienced this fault. Units which have not experienced the fault may be used as normal. A software upgrade is planned.

This action has been closed out on 30/10/2018

This action has been closed out on 30/10/2018

This action has been closed out on 30/10/2018
Contact Information 1800 793 011 - Mindray Customer Service