Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carestream Health 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-2013-RN-01022-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-03
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Carestream health australia 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 v11.42) the exam type is from multi-slice modalities3) 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
    Users are advised that the software patch will be installed by Carestream Health Australia's engineers to address the problem. Users are also informed that should a user notice the problem prior to deployment of a permanent fix, it can easily be resolved by reapplying the same display protocol.

Device

  • 모델명 / 제조번호(시리얼번호)
    Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4Catalogue number & description:1308519 VIRT PWR Reading Basic SW Workgroup1530633 VIRT PWR Reading Basic SW 8 Pack1467067 Virtual Reading Basic SW Workgroup1405794 Virtual Reading Basic SW 8 Pack8171837 Virtual Enterprise SW StandaloneARTG Number: 135310
  • Manufacturer

Manufacturer