Events

ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Karl Storz Endoscopy 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-2016-RN-00200-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00200-1
  • 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 manufacturing defect has been detected which could lead to the loosening of the rivets of the interface plate that connects the monitor and touch screen to the articulating arms on the trolley (vesa 75/ 100 adaptation with rotation). the riveting of the rotation may not have been carried out according to the manufacturer's specifications.In rare cases, it can lead to a loosening of the connection plate and result in injuries to patients and/or users.
  • 조치
    KARL STORZ is advising customers that they can opt for their own engineers to replace the adaptor plates or nominate KARL STORZ to replace the affected component on site.

Device

ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)
  • 모델명 / 제조번호(시리얼번호)
    ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)Lot Numbers: HA.2200.902 and HA.2237.902Multiple Serial Numbers affectedManufactured between 1 June - 26 November 2015.ARTG Number: 168578
  • Manufacturer
    Karl Storz Endoscopy Australia Pty Ltd

Manufacturer

Karl Storz Endoscopy Australia Pty Ltd