Alerta De Seguridad para Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration number: 80569320007. Risk class: III. Affected Model: Integrity ™. Serial numbers affected :. INTEGRITY SOFTWARE / 16966-001 / 3.2.0 ;. INTEGRITY SOFTWARE / 30000301-001 / 3.2.0. INTEGRITY SOFTWARE / 20391-001 / 3.2.0. INTEGRITY SOFTWARE / 30000515-002 / 3.2.0. INTEGRITY SOFTWARE / 30000683-001 / 3.2.0

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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 Important Safety Notice 200-01-502-053. Send your signed Elekta representative as soon as possible the signed document receipt. Allow Elekta Service representatives to access to install the modification when it is launched. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made 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 Additional information: - Date of identification of the problem by the company: 10/20/2017 - Date of notification notice to Anvisa: 01/18/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • 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 correction in the field.