Events

Elekta Monaco Radiation Treatment Planning System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Elekta 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
    14762
  • 사례 시작날짜
    2013-06-06
  • 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
    Patients can be scanned either head first or feet first and these cts imported into monaco for radiation treatment planning. the monaco ct sim workflow gives an option to prepare a feet first plan, but monaco imrt workflow does not. although a patient can be scanned feet first and these feet first cts imported into monaco, the user could incorrectly assume that the intensity-modulated radiation therapy (imrt) plan is feet first as well. when the patient is treated, they could be incorrectly positioned in the feet first position which will not match the plan. if the patient is positioned for treatment in the feet first position, the imrt treatment plan will not match what is delivered, potentially resulting in a significant beam geometry error.
  • 조치
    Instructions for use to be updated

Device

Elekta Monaco Radiation Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: All versions
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc