Events

Elekta linear accelerator 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Elekta Limited || Elekta Instrument Ab 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1609-401
  • 사례 연번
    2009EBC-0005074
  • 날짜
    2016-09-27
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has determined that when a plan3d of monaco is exported through dicom and the check box "composite field sequencing" (cfs, [field composition sequencing]) is selected, the jaws y are set to the shape of the port, despite that they should continue how and where they were defined. this fact takes place when the shape of the port used to define or edit the positions of the mlc extends beyond or within the actual positions of the jaws, the problem is when a workflow is used for the imrt with direct planning involving the creation of several you do for the same gantry angle with a single mlc shape defined for each beam, these beams then see the cfs to combine the individual 3d beams into a single sequence of imrt beams, leading to an overdosage or receive less than necessary, which could potentially cause the presentation of adverse events on the patient.

Device

Elekta linear accelerator
  • 모델명 / 제조번호(시리얼번호)
    AXESSE, SYNERGY and INFINITY, MONACO software version v5.11 and 5.20, specific serials.
  • 제품 설명
    This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved.
  • Manufacturer
    Elekta Limited || Elekta Instrument Ab

Manufacturer

Elekta Limited || Elekta Instrument Ab
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    NIDFSINVIMA