syngo Workflow MLR 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-00097-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-07
  • 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
    While creating or modifying a report using microsoft word application in classic client, when content is pasted form an external source including the formatting 'section break' or by inserting it manually, data from the pre-defined sections of the template might not be saved to the syngo workflow mlr database. this incomplete report from the database issued for distribution to external systems e.G. his, pacs or fax. in the classic client report viewer the content is complete.To date, no harm has been reported as a result of this issue.
  • 조치
    Siemens is preparing a correction to rectify this issue. In the interim, users are advised to always use the standard report creating options of syngo Workflow MLR Classic Client: 1. Use the online speech recognition to dictate the report with the supplied microphone. 2. Type content in the report editor. 3. Use auto text module to speed up the reporting process. 4. Only copy/paste from ASCII view of prior reports in syngo Workflow MLR Classic Client. In the case that users cannot avoid copy and pasting within the same document or from external applications, on all syngo Workflow MLR workstations the default paste option of the Microsoft Word application shall be set to 'KeepTextOnly'. Users may refer to the Customer Letter for further instructions regarding this. In the event that a report was created using copy and paste, users should always verify the content for completeness. Instructions for this are provided in the Customer Letter.

Device

  • 모델명 / 제조번호(시리얼번호)
    syngo Workflow MLRCatalogue Lot number: 10014099ARTG Number: 184557 - cancelled
  • Manufacturer

Manufacturer