Events

EXACT TARGETING MESA, component of the following products: ACUITY RADIAC THERAPY SIMULATOR (Anvisa 10405410008), LINEAR ACCELERATOR CLINAC IX AND ACCESSORIES (Anvisa Reg 10405410012), VARIAN RADIOTHERAPY SYSTEM (10405410011), CLINAC RADIOTHERAPY LINEAR ACCELERATORS (10405410001) and LINEAR HIGH-ENERGY RADIOTHERAPY ACCELERATOR CLINAC (10405410010). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Varian Medical Systems Brasil Ltda.; Varian Inc. 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
    1037
  • 날짜
    2010-12-15
  • 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 EXaCT Targeting table is a complex mechanical device that can trap and injure the extremities of the human body, especially the fingers. Documentation already provided by Varian for this table includes warnings about these risks and instructions for safe use of the table. According to Varian, in the past mitigation measures have been taken.
  • 원인
    Grooves on the tables can hold and injure parts of the operator's or patient's extremities, such as the fingers and toes.
  • 조치
    Users of Exact Targeting should pay attention to the following instructions: Read and follow the recommendations and safety instructions in the user manual that came with the product, especially the chapter "Hazard and Safety Precautions" ). Maximum caution is advised when two people handle the table simultaneously. Patients should be advised to hold only the appropriate handles and guides on the table to avoid inserting their fingers into risky places. For detailed safety instructions, please read the Urgent Safety Notice posted by the manufacturer of the product at: http://portal.anvisa.gov.br/wps/wcm/connect/313eef8045112cd3ac7daeb34d2284eb/VarianSecurity Notice. pdf? MOD = AJPERES.

Device

EXACT TARGETING MESA, component of the following products: ACUITY RADIAC THERAPY SIMULATOR (Anvis...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Inc.