Events

Specular Microscope SP-1P (non-invasive photographic microscope) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2014-RN-00771-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00771-1
  • 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 attention of topcon corporation that during the analysis of large corneal endothelial cells captured by the “specular microscope sp-1p” the unit may provide higher than actual cell count. topcon corporation found that in some cases when an image with large corneal endothelial cells (approximate cell density 1,500 cells/mm2 or less) was analysed the cell density may be higher due to a smaller cell area. consequently, when an image with large corneal endothelial cells is analysed by the current auto-analysis software, it detects the core of the cell as a cell wall, hence one cell would be recognised as two or more cells.
  • 조치
    Device Technologies is providing a software upgrade to improve the detection of large size cells. End users are advised to evaluate the examination result of the Specular Microscope SP-1P not only with the resulting cell count, but also by reviewing the captured image while awaiting the software upgrade. This action has been closed-out on 19/02/2016.

Device

Specular Microscope SP-1P (non-invasive photographic microscope)

Manufacturer

Device Technologies Australia Pty Ltd