Events

Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) 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-2014-RN-00417-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00417-1
  • 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
    An issue has been found with the ingenuity core128 system with software version 3.5.5. if additional acquisitions/scans are requested prior to completion of the current reconstructions, not all planned images from the current reconstruction are displayed to the user. users may not be aware the information is not lost, as the raw data can be reconstructed off-line displaying all requested reconstructions. if a rescan is required, there is potential for unnecessary radiation.
  • 조치
    Philips is requesting customers to verify that all planned image reconstructions are completed and to perform off-line reconstructions, if expected images are missing. Philips will be installing a software update to correct the issue. This action has been closed-out on 01/02/2016.

Device

Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray s...
  • 모델명 / 제조번호(시리얼번호)
    Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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