Events

Alerta De Seguridad para 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%

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2472
  • Fecha
    2018-01-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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
  • Causa
    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.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    ANVSANVISA