Events

Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic X-ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2015-RN-00755-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00755-1
  • 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
    Some scans unexpectedly set the axial (z axis) scan length to a greater length than the user set in the plan.The issue occurs only when the following 3 conditions are met:· the plan employs dual-surview· the plan requests either a sagittal or a coronal reconstruction.· the gantry is tilteddue to this issue, there is a potential for undesired radiation to areas not intended to be scanned.
  • 조치
    Philips is developing a new version of software that will eliminate the defect. Deployment of this new software will begin before the end of April, 2016. All customers will be updated by the end of October, 2016. In the interim, to eliminate the possibility of the defect from occurring, the user can eliminate any one of the three conditions (identified above) needed to trigger the behaviour. If the user chooses to eliminate the reconstruction from the plan, then that reconstruction can be created after the scan is complete. This action has been closed out on 15 June 2017.

Device

Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (...
  • 모델명 / 제조번호(시리얼번호)
    Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic X-ray system)4.0.x.xxxx – Any version of 4.04.1.y.xxxx – Only version up to and including 4.1.4.ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA