Events

Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound 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-2013-RN-01095-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01095-1
  • 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 procedures where the 4d tee (6vt-d) probe is used over an extended period of time, the vivid e9 scanner may gradually become unresponsive with the result that the vivid e9 scanner must be rebooted. this event may lead to possible risk to patients, when performing transoesophageal echocardiography (tee).
  • 조치
    GE Healthcare is providing a correction to be installed by a GE service engineer. End users are advised to reboot the scanner if it becomes unresponsive. A reboot should take approximately 2 minutes.

Device

Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system)
  • 모델명 / 제조번호(시리얼번호)
    Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system) Affected serial numbers: between VE94165 and VE95415ARTG Number: 146317
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd