Events

M320 Microscope Systems Article 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-2018-RN-00652-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00652-1
  • 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
    Internationally, three complaints were reported involving mechanical part failures for the leica m320 microscope system. these specific systems had failures with the screws that hold the gas spring fixation bracket in place . due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. this may potentially cause the m320 optics carrier to drop to the lower mechanical end stop.This failure was identical in all three complaints and has been linked to an identified batch of screws, used in the manufacture of the gas spring fixation bracket. these screws have been determined to be non-conforming. in the event that this observed defect were to occur, the m320 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
  • 조치
    Leica is advising they will contact affected users to arrange replacement of the mechanical parts of the parallelogram for all M320 microscopes manufactured with screws from the nonconforming batch.

Device

M320 Microscope Systems Article
  • 모델명 / 제조번호(시리얼번호)
    M320 Microscope Systems Article/Catalogue Numbers: 10448419, 10448420, 10448485 and 10448486 Manufactured between 18 May 2014 and 21 January 2015.ARTG: 137683LEICA MICROSYSTEMS - Microscope, surgical,
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd