Events

Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-2014-RN-01067-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01067-1
  • 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
    The epi2alt feature which is a type-in pulse sequence database (psd) recently introduced in the dv25 software release that was intended to help a different brand users transitioning to ge scanners, contains a software issue in which images may be flipped and annotated incorrectly. this image orientation error will affect all axial, sagittal, and coronal diffusion-weighted echo planar imaging (epi) scans using the ‘epi2alt’ type-in (psd) in conjunction with the ‘focus excitation’ option when the number of excitations (nex) is set to larger than 1. no other psds or imaging options are affected by this issue. no injuries have been reported due to this issue.
  • 조치
    GE Healthcare recommends that users discontinue use of the type-in ‘epi2alt’ PSD option. Users may continue to use all diffusion-weighted EPI scans available through the user interface.

Device

Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with t...
  • 모델명 / 제조번호(시리얼번호)
    Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System)ARTG Number: 223115
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd