Events

APPLICATOR SET IN TANDEM AND RING FOR BRAQUITERAPIA / GAMMAMED EQUIPMENT FOR TREATMENT BY BRAQUITERAPIA. ALL SERIAL NUMBERS. REGISTRATION N ° 10405410009. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Varian Medical Systems Inc. - USA. Varian Medical Systems do Brasil Ltda - Rua Carlos do Pinhal, 696 9° Andar Conj 91-92-93 Bela Vista São Paulo SP CEP:01333-000. 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
    929
  • 날짜
    2008-06-19
  • 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
    According to information from Varian Medical Systems of Brazil Ltda., Only one affected equipment was commercialized in Brazil. The company informed the Anvisa Technovigilance Unit that it has already contacted the hospital user of the product and provided information to assist in correcting the problem. Anvisa's Technovigilance Unit is monitoring this case.
  • 원인
    Inaccuracies in positions within the ring may result in unintended delivery of doses to the patient.
  • 조치
    The user must identify and isolate the equipment under risk and notify the company that owns the product registration in Brazil (Varian Medical Systems Ltda. - Tel: (11) 3457-2655). The product manufacturer recommends that users characterize all ring applicators in order to correct the offset to each equipment stop position - so that the user can build better accuracy and reliability planning. The characterization can be done by creating a set of X-rays with the marking of the stop positions and the definition of the displacement of the planning for the treatment of the appropriate stop positions. After this procedure, the user must perform a new set of x-ray checks using the new offsets, in order to verify the correction of the stop positions.

Device

APPLICATOR SET IN TANDEM AND RING FOR BRAQUITERAPIA / GAMMAMED EQUIPMENT FOR TREATMENT BY BRAQUIT...

Manufacturer

Varian Medical Systems Inc. - USA. Varian Medical Systems do Brasil Ltda - Rua Carlos do Pinhal, ...