Events

Rappel de Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par St Jude Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01403-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-10
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01403-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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