Events

Biograph mCT and Biograph mCT Flow 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-2016-RN-01650-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01650-1
  • 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
    An issue has been identified that the light marker windows used for the positioning laser and integrated into the front cover of the biograph mct or biograph mct flow system may loosen and potentially drop out. in this case, there is a risk that a person could touch the electrical or rotating parts of the gantry in the unlikely event that they reach through the window opening. this could result in a serious injury such as electrical shock or physical harm. there have not been any reports of complaints regarding this issue.
  • 조치
    Siemens is advising users to conduct a visual inspection of their Biograph mCT or Biograph mCT Flow and that in the event that the light market window is missing or loose, they should not use the Biograph mCT or Biograph mCT Flow and should immediately contact their local Siemens Customer Service Engineer for correction of the problem.

Device

Biograph mCT and Biograph mCT Flow
  • 모델명 / 제조번호(시리얼번호)
    Biograph mCT and Biograph mCT FlowCatalogue/Lot numbers: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10250743, 10250745, 10507786, 10528955, 10529159ARTG number: 144218
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd