Events

Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030 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-01196-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01196-2
  • 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
    While performing high resolution head scans, the reconstructed images may exhibit degraded image quality manifested as:- non uniformity of the image, - ct number shift, greater than 5 hounsfield units,- reduction in grey/white matter differentiation. the issue is most severe in the high resolution mode. philips provides factory reference paediatric scan protocols which are set to high resolution by default. adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue.
  • 조치
    Philips is advising users to perform head scan with standard resolution across all patient populations on systems running the affected software. Philips will be implementing a software correction as a permanent correction. This action has been closed-out on 15/03/2018.

Device

Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030
  • 모델명 / 제조번호(시리얼번호)
    Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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