Events

SEQUENCER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC 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
    33120
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-11-08
  • 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
    Issue with mosaiq that could affect any treatment field defined with mlc leaves at the time of rtp import of treatment plans. a product defect truncates the mlc leaf values upon the import of a treatment plan after the 3d image viewer has been opened if the workstation on which the import was executed is configured to use a comma() as the decimal separator. this involves sequencer for mosaiq 2.20.08 (first build released may 2011) including all released builds and service packs of version and version 2.00x3sp6 (first build released sept 2011).

Device

SEQUENCER

Manufacturer

ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC.
  • 제조사 주소
    SUNNYVALE
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    HC