Events

Elekta Mosaiq 2.5 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 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
    19557
  • 사례 시작날짜
    2015-12-10
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • 원인
    Incorrect drug dosage due to "age limit" data item issue:, when there is no valid (unexpired) patient weight entered on the same date or prior to a serum creatinine value being populated, a stale creatinine clearance (crcl) value is being used in area under the curve (auc) dose calculations., incorrect drug dosage due to patient weight data item issue:, if there is a valid age limit added to an elekta metric data item (eg; weight (kg)) and the same valid age limit has not been added to the elekta imperial data item which corresponds (eg; weight (lb) ), the calculated result which has no valid age will still be considered valid and could be used in drug calculations., if a stale dose calculation is used in dose calculations the dose may be incorrect.
  • 조치
    Software to be upgraded

Device

Elekta Mosaiq 2.5
  • 모델명 / 제조번호(시리얼번호)
    Model: Mosaiq, Affected: , Software version: 2.5 and higher
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc