Events

MAGNUS Hybrid OR table column 1180.01B2 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-2015-RN-00466-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00466-1
  • 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 have been made aware of a complaint regarding a reported collision between the c-arm of the angiography-system and the magnus or table system. the root cause analysis has shown that the magnus column provided the wrong position data for the longitudinal movement. thus the collision calculation of the angiography-system led to an incorrect result. it was diagnosed that the magnus or table system may provide incorrect position data for particular movements in very rare cases after switching on the angiography-system. if this occurs, the system at the latest operates properly again after activating the corresponding movement.
  • 조치
    A MAQUET service technician will be contacting users to arrange an appointment to update the software free of charge. Until that occurs users should activate all movements of the OR table system for a short time after switching on the angiography-system. The operator always has to observe the movement of the C-arm to have the possibility to react early enough if required.

Device

MAGNUS Hybrid OR table column 1180.01B2
  • 모델명 / 제조번호(시리얼번호)
    MAGNUS Hybrid OR table column 1180.01B2Serial number 00001 to 00100
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd