Events

Recall of Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by St Jude Medical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01403-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01403-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices
  • Model / Serial
    Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devicesModels: PM1210, PM1224, PM1240, PM1272, PM2212, PM2224, PM2240, PM2272, PM3212, PM3222, PM3242 and PM3262ARTG Numbers: 163890, 185763, 216284, 267512, 163892, 185764, 216285, 267513, 163894, 216290, 216291 and 231759
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA