Events

Merge CADstream, All versions (used for breast cancer or general MRI studies) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-2016-RN-00866-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00866-1
  • 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
    Within the sureloc application, under sureloc preferences, there are two grid options: a generic grid or the ge 8-channel curved grid. a generic grid is a flat grid of 2 centimeter holes. there is no limitation on the number of blocks. selecting the incorrect grid or using an unsupported grid could result in an incorrect biopsy or missed target. there is a chance that a repeat biopsy may be required.
  • 조치
    Emergo is advising users to ensure a verification scan is completed as per the User Guide to confirm correct placement prior to undertaking a biopsy. Users are also advised that if they are using a grid outside the two defined options, please contact Merge support. This action has been closed-out on 27/02/2017.

Device

Merge CADstream, All versions (used for breast cancer or general MRI studies)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia