Events

Alerta De Seguridad para RADIOTERAPIC LINEAR ACCELERATORS MODELS: CLINAC HIGH ENERGY, LOW ENERGY, CX, iX, UNIQUE and TRILOGY. Anvisa Registry: 10405410001, 10405410010, 10405410011, 10405410012 and 10405410017.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VARIAN MEDICAL SYSTEMS BRASIL 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
    1240
  • Fecha
    2013-03-04
  • 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
    Varian is sending a "Warning Caution" letter to users of their linear radiotherapy accelerators, alerting them to the importance of monitoring and maintaining the performance of such equipment - operating equipment that is malfunctioning can cause serious injury or death. For additional information, please refer to the Caution Notice issued by the company at http://portal.anvisa.gov.br/wps/wcm/connect/9b70d9804f23a512b85abcc88f4b6a31/Aviso_de_Precaucao_Varian.PDF?MOD=AJPERES.
  • Causa
    Caution notice from the manufacturer regarding the monitoring and maintenance of linear accelerator performance.
  • Acción
    Varian advises users to: a) follow the guidelines provided in the user manuals for the linear accelerators of the models cited in this alert; b) notify all persons in the radiotherapy department of the contents of the letter (Warning of Caution) sent by the company; c) attach a copy of said letter in the user manuals of the respective equipment.

Device

RADIOTERAPIC LINEAR ACCELERATORS MODELS: CLINAC HIGH ENERGY, LOW ENERGY, CX, iX, UNIQUE and TRILO...

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.