Events

Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CELEO 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-00167-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-02-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00167-1
  • 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
    During internal testing, the manufacturer vital images has found that an error can occur when images are rotated in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. this orientation adjustment has been found to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty nine percent and in volume measurements of up to fifty percent.
  • 조치
    Vital Images recommends that all measurements associated with the issue are verified against results from other technologies. A software patch is under development to correct the issue.

Device

Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)
  • 모델명 / 제조번호(시리얼번호)
    Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images)All versions prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3ARTG Number: 142791
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    CELEO Pty Ltd

Manufacturer

CELEO Pty Ltd
  • Source
    DHTGA