Events

syngo Imaging XS and syngo.plaza (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-01235-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01235-1
  • 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
    Printouts may be printed in incorrect anatomical size when using syngo imaging xs/ syngo.Plaza filming application to print in anatomical size with a printer not appropriate for anatomical printing. this may happen due to an invalid combination of printer and the printer configuration file.
  • 조치
    Only printers identified in the customer letter are validated to be used for anatomical printing. Siemens is recommending users to check their anatomical printouts by using the scale at the right-hand edge of the printout. The distance between two graduation lines corresponds to one centimetre in the anatomy. Please calculate any distances measured on the printout to correspond with this scale prior to printing. If customers have any printer which is not suitable for anatomical printing, they are advised to contact the Siemens Sales Representative. This action has been closed-out on 07/06/2016.

Device

syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)
  • 모델명 / 제조번호(시리얼번호)
    syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)syngo Imaging XSModel numbers: 7502029 and 10496279, syngo.plaza Model numbers :10863173, 10592457 and 10863171ARTG number: 120332
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd