Events

Multiple Vivid Ultrasound Products Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0 Vivid S70/S60 with software version 201, revision 55.0 and 63.0Vivid S70N/S60N with software version 201, revision 63.0 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-2017-RN-00390-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00390-1
  • 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 whereby another patient other than the one intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. this issue could lead to misdiagnosis. to date, there have been no injuries reported because of this issue.
  • 조치
    GE Healthcare is advising users to follow the "Safety Instructions" as detailed in their recall notification letter. Users are further advised that a GE Healthcare representative will contact them to arrange for a free correction of all affected products.

Device

Multiple Vivid Ultrasound Products Vivid E95/E90/E80 with software version 201, revision 54.0 and...
  • 모델명 / 제조번호(시리얼번호)
    Multiple Vivid Ultrasound ProductsVivid E95/E90/E80 with software version 201, revision 54.0 and 61.0Vivid S70/S60 with software version 201, revision 55.0 and 63.0Vivid S70N/S60N with software version 201, revision 63.0ARTG Number: 146317
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd