Events

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT PREMIUM EDITION 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS CANADA LIMITED - HEALTHCARE 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
    78789
  • 사례 위험등급
    II
  • 사례 시작날짜
    2009-09-11
  • 사례 국가
    Canada
  • 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
    1)doppler signals may be truncated and peak gradients to be potentially obscured may result in the underestimation of peak velocity and a disease process 2)user records of heart be recorded using calipers on the ecg the heart rate value does not get reset during a new patient registration and calculations are based on the previous patient's results. 3)when a user searches for data the search result is for the patient in the study browser new study results are saved under patient the study brower is focused on. 4)when new patient is registered with no new parameters image from the last patient is appearing in the text for the new patient could result in misdiagnosis.

Device

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT PREMIUM EDITION

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    HC