Events

Vivid and LOGIQ Ultrasound Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-00359-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00359-1
  • 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
    Ge healthcare has identified that the system side of the power cord for certain vivid and logiq ultrasound systems may break and expose the electrical conductors leading to the risk of shock. this can lead to injuries up to and including cardiac arrhythmia or cardiac arrest. a minor injury has been reported overseas as a result of this issue.
  • 조치
    GE Healthcare will contact users to arrange for a replacement cord to be provided. In the interim, users may continue to use their system until the correction has been implemented only if the system end of the cord is not damaged. Users should ensure all power to the unit is turned off prior to removal of the power cord.

Device

Vivid and LOGIQ Ultrasound Systems
  • 모델명 / 제조번호(시리얼번호)
    Vivid and LOGIQ Ultrasound SystemsLOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95 ultrasound systems which have been installed since April 2015 or which have received a power cord replacement since April 2015.ARTG Numbers: 126295, 146317 and 221395
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd