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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01403-1
Product Name/Description	Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices Models: PM1210, PM1224, PM1240, PM1272, PM2212, PM2224, PM2240, PM2272, PM3212, PM3222, PM3242 and PM3262 ARTG Numbers: 163890, 185763, 216284, 267512, 163892, 185764, 216285, 267513, 163894, 216290, 216291 and 231759
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/11/2017
Responsible Entity	St Jude Medical Australia Pty Ltd
Reason/Issue	St Jude Medical (SJM) is advising of the availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorised access to our pacemakers that utilise radio frequency (RF) communications (i.e. Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI). This firmware update provides an additional layer of security against unauthorised access to these devices that further reduces the potential for a successful cybersecurity attack. This release is part of planned updates that began with the January 2017 enhancements of the Merlin@home v8.2.2 software. The update contains a software release for Merlin programmers including data encryption, operating system patches, and disabling network connectivity features in addition to the firmware update.
Recall Action	Recall for Product Correction
Recall Action Instructions	A firmware update from Abbott provides an additional layer of security against unauthorised access to these devices that further reduces the potential for a successful cybersecurity attack. Abbott will provide users of the Merlin Programmer with a firmware upgrade for the affected pacemakers for doctors to execute at scheduled consultations with recipients. This action has been closed out on 17/10/2018
Contact Information	1800 839 259 - Abbott Customer Service Team