Events

Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 St Jude 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-2017-RN-01403-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01403-1
  • 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
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 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