Events

syngo.plaza(Radiology picture archiving/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-2015-RN-00034-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00034-1
  • 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
    In the event of a system crash (e.G. bluescreen, power outage) the image may not be written from cache to the file system and may be lost in syngo.Plaza. when a further image is received, syngo.Plaza will allocate the same file name for the new image, and after some internal checks it will add the entry to the database for the new image. this gives rise to two references in the database to the same image which may lead to either:· the wrong image being displayed, which means for that series there is an image with a wrong examination parameter, and/or wrong examination (e.G. head/knee) and/or may be the wrong patient. this patient mix-up could lead to a wrong diagnosis, or· data loss in that an image is missing.To date this issue has not been reported by australian customers.
  • 조치
    Siemens is providing a work around for customers whilst a permanent software fix is being developed. This action has been closed-out on 15/07/2016.

Device

syngo.plaza(Radiology picture archiving/communication system)
  • 모델명 / 제조번호(시리얼번호)
    syngo.plaza(Radiology picture archiving/communication system)Lot numbers: 10863171 & 10863173ARTG number: 120332
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd