Events

Synapse Cardiovascular (CV) Software 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fujifilm Australia Pty 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-2018-RN-00504-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00504-1
  • 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
    Fujiflm has become aware of a malfunction in the system where inconsistent mitral valve mean pressure gradient values are being reported. the values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the synapse cv measurement tools. multiple traces measured on the modality and transmitted to synapse cv are not affected.To date, there have been no reported patient injuries as a result of this issue. this malfunction does not impact the advances reporting system and there have been no reports of any other measurements or calculations being affected.
  • 조치
    Fujifilm is advising users not to perform sequential multiple velocity trace measurements for mitral, tricuspid, aortic or pulmonic valves in the Synapse Cardiovascular analysis package. If averaging needs to be performed in Synapse Cardiovascular analysis package, users are advised to follow the steps outlined in the Customer Letter. This issue has been corrected in Synapse CV 6.1.0 and higher versions

Device

Synapse Cardiovascular (CV) Software
  • 모델명 / 제조번호(시리얼번호)
    Synapse Cardiovascular (CV) SoftwareSoftware versions 4.0.2 to 6.0.4.1ARTG Number: 164422(Fujifilm Australia Pty Ltd - Picture archiving and communication system, software)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd