Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication system) 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-2014-RN-00482-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-07
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The “switch user” feature is an option in windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. it has been discovered that running the same synapse cv client application under more than one windows user account simultaneously may cause outbound hl7 reports with incorrect data to be sent to emr. there is the potential that patients’ medical records may be altered as a result of utilizing this windows 7 function through the unintentional modification of the outbound hl7 files. this issue does not occur if individual users logout of windows 7.
  • 조치
    Fujifilm does not support the use of the “Switch User” function in Windows 7 with Synapse CV. The function should be disabled on Windows 7 workstations that operate the Synapse CV application. There are several options to allow multiple users on a workstation and, if required, Fujifilm Customer Support will assist users with determining which option is best suited for each facility.

Device

  • 모델명 / 제조번호(시리얼번호)
    Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication system)ARTG number: 164422
  • Manufacturer

Manufacturer