Events

Secondary 19" Touchscreen - TEGRIS System (Operating room device management system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-2013-RN-00851-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00851-1
  • 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
    A tegris system that has a second touch monitor used to operate the operating room (or) table, is not equipped with an emergency stop button. in an unlikely event of malfunction of the table control module, which could lead to unexpected movement of the or table, this secondary touch monitor could not be used to stop the table in an emergency situation. thus, the intended immediate stop of the table movement could be delayed.
  • 조치
    Maquet is providing instructions to the user to disconnect both the primary and secondary touch screens from the OR table. The table can still be controlled by the corded or infrared hand control. A second emergency stop button will be installed on all existing and future secondary touch screens, which will be available in Australia in October 2013.

Device

Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)
  • 모델명 / 제조번호(시리얼번호)
    Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)Part number: 1707.05A0ARTG number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd