Events

Tegris OR Table Control (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-2014-RN-00917-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00917-1
  • 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
    Maquet has identified a potential issue that might occur with the tegris software module for operating room (or) table integration. the fault is only relevant for customers with a license for the or table control 1703.35a0 module and use it to integrate the magnus operating table system.The button commands for "lower leg up" and "leg down" have been switched in the software for the integration of the magnus operating table system. as a result, when these functions are activated on the tegris touchscreen, the wrong movement is executed. thus far, no incidence has been reported in which a person has been injured or endangered.
  • 조치
    Maquet Australia is advising the customers to discontinue using the Tegris OR Table Control in conjunction with MAGNUS that is equipped with a software version up to 2.1.x.x,. The problem has been resolved as of version 2.2.x.x. A Maquet Service Technician will provide a software update to resolve this issue. This action has been closed-out on 18/03/2016.

Device

Tegris OR Table Control (Operating room device management system)
  • 모델명 / 제조번호(시리얼번호)
    Tegris OR Table Control (Operating room device management system)Part number: 1703.35A0All software versions up to 2.1.x.x are affectedARTG Number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd