Events

Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning) 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-00576-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00576-1
  • 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
    The following issues have been identified which may result in additional patient scanning and threfore additional radiation doses. there have been no reports of injuries as a result of these issues;- sagittal result shortened for axial head scans.- when axial images are acquired with a gantry tilt, the scan increment is manually changed to the same value as the collimation, the console viewer will not allow creation of mpr images due to the scan series being broken into serval series of images.- scan length changes with a change in field of view (fov).- scan length changes on subsequent axial results.- surview scan lengths near 184.4mm & 135.0mm may result in unexpected scan start positions.- there may be a discrepancy between the calculated reconstruction length and the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is not possible.
  • 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.

Device

Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity...
  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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