Events

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032 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-01528-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01528-1
  • 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
    A complaint was received by philips indicating that the non-gated bolus tracking clinical scan failed to initialise with the system displaying the error message:“a problem has occurred; please retry. if the problem persists contact service.” this resulted in the study being cancelled with a loss of bolus. if this were to re-occur, it may necessitate a rescan.
  • 조치
    Philips Healthcare will be installing a software update to correct the issue. A Philips Field Service Engineer will contact affected customers to schedule the software update installation at their site. In the interim, customers are advised that when failure occurs the users may : 1. Continue initiating the diagnostic scan manually. 2. Repeat the bolus tracker scan Customers are also advised to use one of the workaround options provided in the customer letter to prevent the failure of non-gated Bolus Tracking clinical scans with dose modulation.

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.X...
  • 모델명 / 제조번호(시리얼번호)
    Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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