Events

Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Microsystems 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-01256-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01256-1
  • 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
    Leica microsystems has identified that in certain activations of the xy, the system can continue to run laterally to its limit (run-on), but will stop if the surgeon activates any button. run-on of the xy can only occur in the rare situation of rapid consecutive activation on the 45 degrees, 135 degrees, 225 degrees or 315 degrees. in addition, the run-on will stop if any other activation of the xy occurs. the xy run-on is disruptive as the adjustment to the field of view could take up to 24 seconds longer than usual, however there is a low risk to patients.
  • 조치
    Leica is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent fix.

Device

Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)
  • 모델명 / 제조번호(시리얼번호)
    Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)Material Number: 10448505Serial numbers: 260213001, 70613002, 80911001, 110613001, 180712001, 30913001Manufactured from 10 May 2010 to 18 November 2013ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd