Events

GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016 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-2016-RN-00502-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00502-1
  • 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
    Ge healthcare has become aware that an out of tolerance torque tool was used on three joints on your revolution ct system during the manufacturing process. if the x-ray tube becomes loose on the ct gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artefact. there is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. there have been no injuries reported as a result of this issue.
  • 조치
    GE Healthcare is advising users that the scanner can continue to be used. If the X-ray Tube joint loosens, the system would fail internal checks and cause the previous mentioned hazards of beam tracking errors, potential scan aborts and/or image artefacts, requiring immediate action by service to realign the system. Should this occur, stop using the system and call the service team to bring the system back into proper operational status. GE Healthcare will be correcting all affected products. This action has been closed-out on 27/01/2017.

Device

GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016
  • 모델명 / 제조번호(시리얼번호)
    GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016ARTG Number: 156650
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd