Events

Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1(Picture archiving and communication system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo 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-2016-RN-01624-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01624-1
  • 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
    An issue has been identified regarding rf projection images (12 diacom sop classes). if user measures on rf image, “cal” (calibration) is not displayed & measurement is not correct, then the “cal” label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on pixel spacing. measurements are incorrect because efilm is using the imager pixel spacing dicom tag, but it should be using the pixel spacing tag if the value for pixel spacing is present & is differing from imager pixel pacing tag. based on industry practice for projection images, if both the imager pixel spacing and pixel spacing attributes are present and differ, the pixel spacing attribute should be used and the "cal" (for calibrated) label should be displayed.A user will likely be able to notice that the measurements are not as expected. potential health consequence includes delay in patient care and/or change in recommendation for treatment.
  • 조치
    Merge has released a software fix for this issue. The software can be downloaded from its website. Users are advised that they must discontinue using eFilm Workstation/eFilm Lite for viewing of projection images for the affected SOP classes listed in the customer letter until the upgrade is installed and in use.

Device

Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, ...
  • 모델명 / 제조번호(시리얼번호)
    Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1(Picture archiving and communication system)ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia