Events

Brilliance iCT with Software Version 4.1.0.19260 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-2013-RN-01333-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01333-1
  • 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 has detected a situation where ring artifacts may occur. the conditions that may create these specific ring artifacts occur when a user:1. selects a non-gated helical scan with automatic scan time on 2. they edit the preview images using ‘edit before final recon’ (reconstruction); and,3. the automatic scan time algorithm is executed after the scan has been acquired.Presence of ring artifacts affecting diagnostic quality of images may result in a rescan.
  • 조치
    To avoid the occurrence of these specific ring artifacts users can implement the following work around: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking 'Go' to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Reconstruction for all Exam Cards. If ring artifact is present clinical judgement should be used to determine if rescan is required. A software update will be implemented to correct the problem.

Device

Brilliance iCT with Software Version 4.1.0.19260

Manufacturer

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