Events

Alerta De Seguridad para EXACTRAC LOCATION SYSTEM. ANVISA registration no. 80042070004.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BRAINLAB LTDA..

¿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
    1246
  • Fecha
    2013-04-18
  • 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
    The anomaly was detected in EXACTRAC 5.x when it is used with a Treatment Planning System (TPS) not produced by BRAINLAB. The anomaly may mislead the user when he selects a treatment plan / isocenter (radiation treatment target) in EXACTRAC for patient positioning on the linear accelerator (linac). The following versions of EXACTRAC are potentially affected: 5.0 (5.0, 5.0.1, 5.0.2) and 5.5 (5.5, 5.5.1, 5.5.2). See the Field Security Notice issued by the company for additional information. #### UPDATE (06/14/2013): The field action was terminated by the company on 05/08/2013.
  • Causa
    Possibility of unintentional mixing of two planes, initially separated, from the same patient.
  • Acción
    The company will initiate a software update to fix the problem. Until the problem is corrected users should follow the recommendations contained in the USER'S CORRECTIVE ACTION section of the Field Safety Notice issued by the company to mitigate the risks related to this problem. the Notice of Field Security is available at: http://portal.anvisa.gov.br/wps/wcm/connect/77dad1804f4f50a78b86dbd785749fbd/Aviso_de_Seguranca.pdf?MOD=AJPERES

Device

EXACTRAC LOCATION SYSTEM. ANVISA registration no. 80042070004.

Manufacturer

BRAINLAB LTDA.
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    ANVSANVISA