Monaco 5.10.00(Radiation therapy treatment planning system) 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-2015-RN-00910-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-09-16
  • 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
    1)dose and mu incorrect when ct images viewed from the head: ct images are typically presented as if the viewer is standing at the foot of the couch and looking toward the patient’s head. however, for neurosurgery, images are often created as if being viewed from the top of the couch looking toward the patient’s feet. when ct images are created this latter way and imported in monaco, the image is displayed correctly but the electron densities are incorrectly flipped in both the right-left and superior-inferior directions. the dose distribution and monitor units will be incorrect. 2)dose and mu incorrect when using multiple prescriptions with forced densities:when using multiple prescriptions and the first prescription has forced densities, these forced densities are not being maintained with the second prescription. the dose distribution and monitor units will be incorrect as the initial prescription will use forced densities and the second prescription will use ct densities.
  • 조치
    Elekta is advising customers that both problems will be resolved in Monaco Patch Release 5.10.01 which will be available for general release in late September. This action has been closed-out on 19/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Monaco 5.10.00(Radiation therapy treatment planning system)ARTG: 215960
  • 의료기기 분류등급
  • Manufacturer

Manufacturer