MONACO, version 5.10.00 and above (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-01023-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-10-20
  • 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
    1) in version 5.10.01, the isodose control 100% isodose value (second in the list) was linked to the dose normalisation (dn) value so users would always have a known normalisation value linked to 100% when in relative mode. when the 100% isodose value is edited on the isodose control, the dn is automatically updated. if the user does not notice this update & then rescales to a relative isoline & does not read the dn value displayed on the rescale bar, the rescale could be other than intended. 2) in version 5.10.00 or greater, when the user optimises, then changes the bolus assignment of the beams, and then selects “calculate” (not “optimize” again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect. skin doses could either be higher of lower than intended and this increase or decrease in dose could exceed 5%.
  • 조치
    1) The workaround is to only assign one value greater than 100% as the system is defaulted so the 100% isodose line and dose normalisation values are not affected. When rescaling, the dose normalisation value is displayed next to the re-scale value being entered by the user. 2) There is no workaround using the described workflow. However, the problem can be avoided by changing any bolus assignment before optimisation. Both problems will be resolved in Monaco Patch Release 5.10.02. This action has been closed-out on 22/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    MONACO, version 5.10.00 and above (Radiation therapy treatment planning system)ARTG number: 215960
  • 의료기기 분류등급
  • Manufacturer

Manufacturer