Events

Rappel de Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D 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 Abbott 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-2018-RN-00669-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-31
  • 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-2018-RN-00669-1
  • 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
    Further to the safety alert communication of april 24th 2018 (rc-2018-rn-00337-1), abbott is now advising of the firmware update availability.As part of a planned series of system updates that began in 2017 with the release of merlin@home v8.2.2 software, a firmware update has been developed with the intention to further strengthen the security and improve the performance of high voltage implantable cardiac devices (icds and crt-ds). the firmware upgrade is recommended for all eligible patients and includes the following updates:1. a battery performance alert update to provide further detection capability for premature battery depletion in certain high voltage devices (i.E. battery advisory devices), and2. a cybersecurity update to provide an additional layer of protection against unauthorised device access.
  • Action
    The software upgrade indicated in the previous communication RC-2018-RN-00337-1 will be available in the first week of June 2018. Abbott is contacting doctors (physicians) to provide details regarding risk and patient management recommendations. Surgeons should consider the information in the letter and their patient's circumstances in deciding whether to update the firmware in implanted devices.

Device

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Prom...
  • Modèle / numéro de série
    Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D DevicesBattery performance update applies to devices manufactured prior to 23 May 2015Multiple ModelsMultiple ARTG Numbers
  • Manufacturer
    Abbott Medical Australia Pty Ltd

Manufacturer

Abbott 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