Events

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D Devices 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbott Medical Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00669-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00669-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
    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
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “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