Events

Safety Alert for Linear accelerator elekta. Anvisa Registration n ° 80569320007. Models under risk: Digital accelerator Precise, Synergy Platform, Synergy S, Infinity, Axesse.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.; Elekta Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1323
  • Date
    2013-11-05
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Some digital accelerators have increased the settings of automatic screening of the electron applicator in the field to values ​​greater than the factory defaults. The increase in auto-tracking values ​​against factory defaults is against the company's recommendations and may cause the system to not operate in accordance with IEC standards, particularly with regard to the IEC 60601-2-1 safety standard - the Increased auto-tracking values ​​over factory defaults will result in an increase in radiation leakage from the electron applicator in the patient plane as well as around the applicator, which may cause the leakage values ​​to exceed the limits specified in safety standard IEC 60601-2-1. See also the Company Safety Notice at: http://portal.anvisa.gov.br/wps/wcm/connect/0e2b5b8041bb1969933dd79d63c1a945/Aviso_de_Seguranca.pdf?MOD=AJPERES
  • Reason
    Some digital accelerators have increased the settings of automatic screening of the electron applicator in the field to values ​​greater than the factory defaults.
  • Action
    Update of the instructions for use. The company Elekta is announcing to its clients the Important Notice of Field Security, available at: http://portal.anvisa.gov.br/wps/wcm/connect/0e2b5b8041bb1969933dd79d63c1a945/Aviso_de_Seguranca.pdf?MOD=AJPERES

Device

Linear accelerator elekta. Anvisa Registration n ° 80569320007. Models under risk: Digital accele...

Manufacturer

Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.; Elekta Limited
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA