syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-00287-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-07
  • 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
    A software error could allow for two different patients to be displayed in syngo dynamics where, images shown for one patient and reporting system data (worksheet and/or report) shown for a different patient potentially resulting in misdiagnosis due to mix-up in patient data. when this error occurs, a previously opened study is not properly disconnected from the sensis hemodynamics system. only customers using sensis-syngo dynamics integration will face the occasional probability of this error occurring.
  • 조치
    demographics to review the image toolbar and reporting system, and to ensure that toolbar "auto-hide" is disabled. If a patient mismatch is observed, users are advised to close and reopen the study. A software update will be implemented as a corrective measure. This action has been closed-out on 29/01/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system)ARTG Number: 120332
  • 의료기기 분류등급
  • Manufacturer

Manufacturer