SYNGO.VIA 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE LIMITED 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
    98371
  • 사례 위험등급
    III
  • 사례 시작날짜
    2018-01-11
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    The manufacturer has identified a limitation within the syngo.Via vb20a reporting sections. after entering the findings information using the findings assistant or the interactive findings dialogue (ifd) user may check the finding information within the report. in case a correction of finding information should be needed user does the correction in "findings information" section or "summary of measured findings" section. in vb20a versions listed this feature is not working as expected: the corrected values modified in the report are neither saved nor printed nor sent to information system. the system will still use the former values. if the late modifications done on the syngo.Via evidence report are not noticed later when creating the formal report in the reporting system outdated information could be sent to the referring physician.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10496180 (Lot serial: 101689); Model Catalog: 10496180 (Lot serial: 101928); Model Catalog: 10496180 (Lot serial: 101568); Model Catalog: 10496180 (Lot serial: 101386); Model Catalog: 10496180 (Lot serial: 109939); Model Catalog: 10496180 (Lot serial: 101075); Model Catalog: 10496180 (Lot serial: 131196); Model Catalog: 10496180 (Lot serial: 101414); Model Catalog: 10496180 (Lot serial: 101401); Model Catalog: 10496180 (Lot serial: 130766); Model Catalog: 10496180 (Lot serial: 101511); Model Catalog: 10496180 (Lot serial: 131273); Model Catalog: 10496180 (Lot serial: 130294); Model Catalog: 10496180 (Lot serial: 222377); Model Catalog: 10496180 (Lot serial: 102241); Model Catalog: 10496180 (Lot serial: 130666)
  • 제품 설명
    SYNGO.VIA
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • 제조사 모회사 (2017)
  • Source
    HC