Events

Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex. Software versions V3.6.1, V3.6.2, V3.6.4, and V3.6.5 (X-ray system, diagnostic, computed tomography, full-body) 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-00987-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00987-1
  • 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
    Image position accuracy - image rotation calibration program performed by field service engineer can report pass but fail to produce the correct angular rotation offset value for the ultra-fast scan mode. the inaccurate angular rotation offset can impact the accuracy of radiation treatment planning.Tracker image artefact - tracker scan image of ct angiography (cta) examination can exhibit a streaking artefact. due to the streaking artefact, the automatic clinical scan may be triggered at the wrong time resulting in suboptimal ct diagnostic images that do not capture the bolus peak of the imaged body section.Ring/dot image artefact due to x-ray measurement - after a complete system power shutdown and power up, if a head scan is performed without air calibration and without quick iq check scan after power up, intermittent ring/dot image artifacts in the reconstructed images may occur.
  • 조치
    Philips Healthcare are providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent correction. This action has been closed-out on 31/08/2016.

Device

Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brillian...
  • 모델명 / 제조번호(시리얼번호)
    Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex. Software versions V3.6.1, V3.6.2, V3.6.4, and V3.6.5 (X-ray system, diagnostic, computed tomography, full-body)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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