Events

Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems) 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-00197-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00197-1
  • 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
    1- swirl-like ring artifacts may appear on reconstructed images impairing the diagnostic quality.2- when executing two bolus scans the system may freeze during the second tracker execution, impacting countdown timer displayed to the user which indicates the start of the clinical scan. 3- there are inconsistencies between the gui and the instructions for use (ifu)/technical reference guide (trg): english version 459800340361_a documentation for the (qa) testing4- teflon and other pins hu values are incorrectly documented in the ifu/trg.
  • 조치
    Philips is provided information and work around instructions to mitigate some of the issues. A software update and revision of the Instructions for Use (IFU) documentation will be implemented to correct the issue.

Device

Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole ...
  • 모델명 / 제조번호(시리얼번호)
    Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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