Events

Monaco (with the use of Elekta Motorised Wedges) 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-2017-RN-00051-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00051-1
  • 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
    An issue has been identified where the calculated dose from wedged beams can be assigned to the wrong beam. this can occur for a plan with at least two beams using the elekta motorised wedge. as a consequence, a geometric miss would result with the dose distribution not reflecting what is delivered to the patient.
  • 조치
    As a temporary fix, Elekta is advising users to change the beam index numbers belonging to the two wedged beams, such that the index numbers are exchanged for these beams, then edit the wedge angle of one of the beams. The problem will resolve itself if a recalculation is forced after the beam numbers are edited and the wedge angle is modified, A permanent fix in the form of a software update is anticipated to be released by the end of May 2017.

Device

Monaco (with the use of Elekta Motorised Wedges)
  • 모델명 / 제조번호(시리얼번호)
    Monaco (with the use of Elekta Motorised Wedges)Software versions: V 5.10.00 (including 5.10.01, 5.10.02)V 5.11.00 (including 5.11.01)V 5.20.00ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd