Events

Carestream PACS Client Workstation 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Carestream Health Inc 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
    15496
  • 사례 시작날짜
    2013-10-16
  • 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: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
  • 원인
    Carestream health has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios. this problem occurs infrequently and only when all of the following conditions are met:, 1) the version installed is v11.3.2 or v11.3.2.4 or v11.4, 2) the exam type is from multi-slice modalities, 3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images., 4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
  • 조치
    Software to be upgraded

Device

Carestream PACS Client Workstation
  • 모델명 / 제조번호(시리얼번호)
    Model: Catalogue numbers: 1308519, 1530633, 1467067, 1405794, 8171837, Affected: Software Versions: 11.3.2.0 / 11.3.2.4 / 11.4
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc