Events

Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W Illumination 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-2016-RN-00158-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00158-1
  • 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
    It has come to the manufacturer's attention that an electronic component of the leica m525 oh4 and leica m720 oh5 surgical microscopes with 400w illumination could lead to an unforeseen behaviour:an electronic component in one of the two illumination units can potentially overheat, resulting in modest smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
  • 조치
    Leica is advising users that the microscope will continue to function if the failure occurs, and is providing users with instructions on how to switch the microscope to the back-up illumination unit. Leica will be providing a replacement power supply cable to prevent the issue from occurring. This action has been closed-out on 25/01/2017.

Device

Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W Illumination
  • 모델명 / 제조번호(시리얼번호)
    Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W IlluminationMaterial Numbers: 10448480 and 10448662Serial Numbers: OH5-31311, OH5-51813, OH5-53113, OH5-55313, OH5-53413, OH5-57013, OH5-56613, OH4-107114 and OH5-67314ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd