Events

Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration number: 80569320007. Risk class: III. Affected model: Integrity R1.2 .. Affected serial numbers: See list of affected lots attached in Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content /home % 3DF% 3Dview% 3Dp% 3Dview% 26p_p_col_id% 3Dcolumn% 3pp% 3D2% 26p_p_col_count% 3D5% 26p_p_col_count% 3D5% 26p_p_col_count% 3D5% 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta Ltd 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
    2472
  • 날짜
    2018-01-18
  • 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
    Read and follow the 200-01-502-053 Field Action Safety Notice and send the signed acknowledgment of receipt of the document to your Elekta representative as soon as possible. Please allow Elekta Service representatives to access the Unit to install the patch modification when it is launched. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Adverse Event (AE) and Technical Complaints (QT) for products subject to Sanitary Surveillance should be done through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • 원인
    Potential for positional errors after automatic table movement (atm) elekta has identified that it is possible to obtain a positional error with the precise treatment table ™ after automatic table movement. this may occur if there is an undetected failure of the position sensors. this problem was previously reported through 200-01-204-011 notification. the precise treatment table is equipped with sensors that achieve a high degree of reliability when reading the table position. if there is an undetected fault on one of these sensors, a positional error can be obtained with the precise treatment table ™ after automatic table movement when using the xvi and mosaiq ™. the system has a software check to detect large positional errors resulting from sensor malfunction. in these cases, it is possible to position the treatment table with errors greater than 5 mm without any inhibitions. this may occur if automatic table movement is used. if automatic table movement is performed by iguide, positional error is detected.
  • 조치
    Field Action Code FCA-EL-0004 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Will make field correction

Device

Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration nu...

Manufacturer

Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta Ltd
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    ANVSANVISA