VARISEED 8.0 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 VARIAN MEDICAL SYSTEMS INC. 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
    90283
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-07-03
  • 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
    Some variseed users have inadvertently entered a source activity in units of air kerma (u) when the actual source activity was specified in millicuries (mci). variseed requires the user to enter the activity of the source that will be implanted into the patient. the activity may be entered in "u" or "mci". when entering the activity in u the value is accepted and no further message is displayed. if the activity is entered as mci a message is shown indicating that variseed will show "u" in the user interface from that point on and notifying the user of the convered value in u. a data entry error of this nature should be obvious to the user. the variseed software system provides a message at the time data is entered that the user has to click to accept and move forward in planning. also both units of activity are shown on the variseed report headers.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 8.0 (Lot serial: Contact manufacturer.); Model Catalog: 8.0 (Lot serial: >10 serial numbers.)
  • 제품 설명
    Variseed 8.0 (Brachytherapy Treatment Planning System)
  • Manufacturer

Manufacturer