Events

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software version 4.1.3, 4.1.4 and 4.1.5 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-2016-RN-00681-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00681-1
  • 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
    Philips healthcare became aware of certain issues with the affected products through testing and customer feedback. the identified issues include;- imr cardiac - irregular appearance of contrast in vessels; -missing image annotation’s in cct;- halo artefacts;- unable to match z locations on prescan and 4d ct scan;- incorrect z annotation on plan box for coronal/sagittal surviews;- unintended change of acquisition timing on scan ruler;- bolus tracker does not trigger as expected; - system unresponsive when paused;- system becomes unresponsive during timed scan;- unplanned results during multi-phase pulmo series, may cause a system crash;- communication errors between host computer & gantry; and - pin wheel artefact using 0.67mm slice width.
  • 조치
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software version 4.1.3, 4.1.4 and 4.1.5
  • 모델명 / 제조번호(시리얼번호)
    Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software version 4.1.3, 4.1.4 and 4.1.5ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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