Events

NX workstation with NX 3.0.8950 image processing software 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AGFA HealthCare Australia 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-2017-RN-00131-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00131-1
  • 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
    Due to a memory issue, users are shown a warning message about unexpected error and possible incorrect data integrity. a reboot of the workstation computer after having received the warning message prevents the issue from occurring. at this stage, there has been one instance whereby the warning instructions were not followed and resulted in the image of one patient being archived in another patient’s record.
  • 조치
    In order to prevent this issue, Agfa HealthCare is advising users to conduct a daily reboot of their workstation by completely turning off the computer and then restarting it. Users are further advised to follow all warning instructions as indicated on their NX workstation and reboot the workstation’s computer if a warning message appears. A new version of the NX software (3.0.9000) will be released shortly and users will receive this upgrade to their installations accordingly.

Device

NX workstation with NX 3.0.8950 image processing software
  • 모델명 / 제조번호(시리얼번호)
    NX workstation with NX 3.0.8950 image processing softwareARTG Numbers: 119463, 173861, 178856
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia