Events

Alerta De Seguridad para THREE-DIMENSIONAL PLANNING SYSTEM FOR ECLIPSE RADIOTHERAPY. ANVISA Registration No. 10405410007.

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
    1188
  • Fecha
    2012-10-03
  • 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
    Additional information available in the warning message published by the company at http://portal.anvisa.gov.br/wps/wcm/connect/d7a881004cf28281bdd1bf551355428f/Messaje+de+Alerta_1188.pdf?MOD=AJPERES. The company did not report the date of completion of the fix. #### UPDATE (06/07/2013): The company completed the field action on 04/29/2013, correcting the 52 units under risk in Brazil.
  • Causa
    Possibility of calculation and application of incorrect dose of radiation, due to lack of synchronism between the clocks of the workstation and the server of the system / database.
  • Acción
    The company is notifying its customers through an "Urgent Security Warning" notice, which advises users to check the synchronization between Workstation and System / Database Server clocks. The company is developing a technical solution to the problem (software).

Device

THREE-DIMENSIONAL PLANNING SYSTEM FOR ECLIPSE RADIOTHERAPY. ANVISA Registration No. 10405410007.

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.