SERVER SOFTWARE 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
    32765
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-04-14
  • 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
    A potential issue when using "in-progress" invasive reporting with sensis integration to syngo dynamics v9.5. the issue occurs under the following conditions: - sensis-syngo dynamics integration - sensis study is opened from syngo dynamics while still "in-progress" - sensis reference numbers > 1000000 -sensis reference numbers grow in response to hl7 messages even if those hl7 messages are not being utilized by sensis and/or syngo dynamics. sensis reference number greater than 1000000 are wrongly modified during transfer to syngo dynamics. when this happens during "in-progress" reporting a study will get a sensis reference number for the wrong study in sensis. this causes an incorrect 'link' between the syngo dynamics images and the sensis study data. if this happens customers will have to call siemens service team. there has not been any patient consequence reported from the installed base.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10091862 (Lot serial: S/N 85162); Model Catalog: 10091863 (Lot serial: S/N 85182)
  • 제품 설명
    SERVER SOFTWARE
  • Manufacturer

Manufacturer

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