Events

Product: RT Elements. Models: Brain Metastases Elements and Adaptive Hybrid Surgery Analysis Elements. Anvisa Registration n ° 80042070036. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Brainlab Ltda; Brainlab AG 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
    1792
  • 날짜
    2016-01-14
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    The manufacturer assessed the situation and concluded that: In the case of Brain Metastases, if the trimmed object is not recognized by the user before the plan is used for treatment and the deviation exceeds the clinically acceptable limits, this may result in ineffective radiation treatment and the patient's health risk can not be excluded. In the case of the Adaptive Hybrid Surgery Analysis Elements, when evaluating a possible radiotherapeutic treatment the incorrect information displayed may have an effect on clinical decisions. If the evaluation of different treatment options is performed during surgery, this may even, in a worst-case scenario, confuse the patient in relation to the evaluation of the extent of resection during this surgery.
  • 원인
    Large objects with high resolution are potentially displayed with cutouts when imported into brain metastases elements and adaptive hybrid surgery analysis elements.
  • 조치
    This is a software update initiated by the company. Users of Brain Metastases Version 1.0.0 or Adaptive Hybrid Surgery Analysis 1.0.0 should note the following instructions: After importing, always review and carefully check for the correctness and validity of all objects. To review an object, select the sequence of images that was used to bypass or modify the objects in the Data menu. Also compare the contours of an object in the Brain Metastases or Adaptive Hybrid Surgery Analysis software with the contours in the SmartBrush. Note that the error will not be visible in SmartBrush. Always verify that the shape of the objects is correct in Brain Metastases or Adaptive Hybrid Surgery Analysis software. If possible, do not use series of image data with long cut distance and / or a small number of cuts. To check retroactively whether scrap objects were used for treatment planning, the contours of the objects in a specific treatment plan can be reviewed in the Brainlab Dose Review software, where the error will also be visible. Company code for the field action: CAPA-20151029-001528.

Device

Product: RT Elements. Models: Brain Metastases Elements and Adaptive Hybrid Surgery Analysis Elem...

Manufacturer

Brainlab Ltda; Brainlab AG