Events

Roche Virtuoso software 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    19259
  • 사례 시작날짜
    2015-10-19
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 원인
    The iscan coreo or ventana iscan ht scans slides at 4x, 10x, 20x, or 40x magnifications. for images scanned at 4x, 10x, and 40x magnification in v5.4 and v5.5, the linear and area measurement tools display a value that is 1/5, 1/2 and 2x the actual measurement, respectively. the measurement will be displayed incorrectly regardless of what magnification the image is viewed at., customers who have used the measurement tool for slides that were scanned at 4x, 10x, or 40x to assist with a diagnosis, need to be aware that an incorrect estimation of clinical stage could lead to improper treatment., for images that are scanned at 20x magnification, the measurement tools work properly in all versions of virtuoso including versions 5.4 and 5.5.
  • 조치
    Software to be upgraded

Device

Roche Virtuoso software
  • 모델명 / 제조번호(시리얼번호)
    Model: 07299303001 (V5.4), 07072984001 (V5.5), Affected: , Software version: 5.4 and 5.5
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479