Events

Safety Alert for ELEKTA LINEAR ACCELERATOR.

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
    1326
  • Date
    2013-11-08
  • 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
    When the user manually turns the table top to its usual position with the spindle rotation equal to 0 °, a spring-tightening screw is felt to engage slightly. You may hear a click sound as soon as the column returns to the notch position. When operating a column rotation, keep the latches off. Make sure that the treatment table is correctly positioned at 0 ° and stable before applying the latch. Releasing the column latch and applying it again causes the treatment table to move to the correct 0 ° position. If it is possible to rotate the speaker with the locks applied, the user should contact an Elekta service representative.
  • Reason
    The spindle rotation may be accidentally moved to a different position, causing treatment error.
  • Action
    Update usage instructions.

Device

ELEKTA LINEAR ACCELERATOR.

Manufacturer

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