Events

Safety Alert for Linear Accelerator Elekta. Anvisa Registry n ° 80569320007.

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
    1316
  • Date
    2103-10-22
  • 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
    Check detailed information in the Alert Message issued by Elekta, available at: http://portal.anvisa.gov.br/wps/wcm/connect/54d4f700418fab298af69ede61db78cc/Alerta_1316_Aviso_de_Seanca.PDF?MOD=AJPERES
  • Reason
    Possibility of changing the contour shapes of the dicom files, which can lead to an error in the clinical treatment.
  • Action
    Sending alert messages and updating the software.

Device

Linear Accelerator Elekta. Anvisa Registry n ° 80569320007.

Manufacturer

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