Events

Safety Alert for ELEKTA PRECISE LINEAR ACCELERATOR. ANVISA Registry 80569320007. Affected units: 105169, 105277, 105338 and 105316.

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..

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
    1185
  • Date
    2012-09-28
  • 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
    According to the record holder, the correction of the problem will be finalized by January-2013. There are four units affected in Brazil, among 23 equipments marketed by the company.
  • Reason
    Semikron diode unit of the equipment chassis may rupture and cause injury to nearby operators.
  • Action
    Equipment operators should wear goggles while working with the modulator unit with the cover removed. The company is already programming the field correction of the equipment.

Device

ELEKTA PRECISE LINEAR ACCELERATOR. ANVISA Registry 80569320007. Affected units: 105169, 105277, 1...

Manufacturer

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