SOMATOM DEFINITION - MAIN UNIT 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
    25800
  • 사례 위험등급
    I
  • 사례 시작날짜
    2013-12-10
  • 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
    Somatom definition ct systems running software version syngo ct 2012b (va44) may experience a malfunction which may lead to a system display freeze during interventional procedures. when the function "auto save last displayed images as key images" is activated during an interventional procedure the software configuration allows conflicting access to the ct system image database which may cause a system display freeze to occur. when this happens normal interaction with the system is no longer possible. no error message is issued and only a system restart resolves the problem. in case of a sudden system display freeze the interventionalist will potentially not immediately recognize the malfunction and continue the interventional procedure. in view of the misleading information shown on the display an injury of the patient cannot be fully ruled out.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 77 40 769 (Lot serial: ALL); Model Catalog: 8098027 (Lot serial: ALL); Model Catalog: 10590000 (Lot serial: ALL); Model Catalog: 10430603 (Lot serial: ALL)
  • 의료기기 분류등급
  • 제품 설명
    SOMATOM DEFINITION -MAIN UNIT
  • Manufacturer

Manufacturer

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