Events

DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital X-ray system) 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-2015-RN-00763-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00763-1
  • 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
    Carestream health has identified a software issue that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (eg. radiopaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there is a risk of undetected stitching errors. this may lead to potential diagnosis errors if measurements taken from just that image wererelied on. any injury resulting from this could lead to delays in treatment or the need for further diagnostic imaging techniques.
  • 조치
    Whilst there have not been any diagnosis errors reported, Carestream Health is conducting this action to update the software on affected devices to correct this issue. In the interim, Carestream Health recommends that the auto-stitching feature is turned off and the manual stitch editor used to create all composite images until the software update has been made to affected devices. This action has been closed-out on 12/08/2016.

Device

DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolutio...
  • 모델명 / 제조번호(시리얼번호)
    DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital X-ray system)ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd