Events

Safety Alert for RADIOTERAPIC LINEAR ACCELERATORS MODELS: CLINAC HIGH ENERGY, LOW ENERGY, CX, iX, UNIQUE and TRILOGY. Anvisa Registry: 10405410001, 10405410010, 10405410011, 10405410012 and 10405410017.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VARIAN MEDICAL SYSTEMS BRASIL 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
    1240
  • Date
    2013-03-04
  • 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
    Varian is sending a "Warning Caution" letter to users of their linear radiotherapy accelerators, alerting them to the importance of monitoring and maintaining the performance of such equipment - operating equipment that is malfunctioning can cause serious injury or death. For additional information, please refer to the Caution Notice issued by the company at http://portal.anvisa.gov.br/wps/wcm/connect/9b70d9804f23a512b85abcc88f4b6a31/Aviso_de_Precaucao_Varian.PDF?MOD=AJPERES.
  • Reason
    Caution notice from the manufacturer regarding the monitoring and maintenance of linear accelerator performance.
  • Action
    Varian advises users to: a) follow the guidelines provided in the user manuals for the linear accelerators of the models cited in this alert; b) notify all persons in the radiotherapy department of the contents of the letter (Warning of Caution) sent by the company; c) attach a copy of said letter in the user manuals of the respective equipment.

Device

RADIOTERAPIC LINEAR ACCELERATORS MODELS: CLINAC HIGH ENERGY, LOW ENERGY, CX, iX, UNIQUE and TRILO...

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.