MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Elekta Pty Ltd 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
    RC-2016-RN-00954-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-20
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    It is possible that a change to an order set will not be saved in the current, open care plan when the following workflow is utilised: 1. open either the care plan edit form or the care plan instance form and leave the form open. 2. select an order set that is part of the same care plan and make a change to the order set. this can be a change to the order set name or label or a change to the drug, dose, administration instructions, etc. 3. the update made to the order set will not be saved in the current, open care plan.Although drug and/or dose information could be edited, but if substantial changes were made to drug information a new order set would be generated rather than editing an existing order set. it is more likely that the edits made would result in non-serious injury (such as administration details, order set name, etc.) there have been no injuries reported as a result of this issue.
  • 조치
    Elekta is advising users to ensure all Care Plan windows are closed prior to making and updates to Order Sets. A software correction will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 225164
  • Manufacturer

Manufacturer