Events

Safety Alert for Clinical Radiotherapy Linear Accelerator with 4DITC - version 10 and 11. Models at risk: Clinac 6EX, Clinac 600C, Clinac IX, Clinac 23EX and Trilogy. Corresponding Anvisa records: 10405410001, 10405410010, 10405410011 and 10405410012.

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.; Varian Medical Systems Inc.

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
    1444
  • Date
    2014-10-23
  • 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
    Sending consecutive ExactTrac signals to the 4D Intgrated Treatment Console may cause unexpected deletion of both the ExactTrac interlocks and the BCCV from the equipment. In the occurrence of the described problem, it is possible to irradiate the patient using a cone different from that specified by the treatment planning, since the BCCV check has not been completed. Varian received no notification of injury to the patient related to the problem. See additional information at http://portal.anvisa.gov.br/wps/wcm/connect/8179950045f00258a0d6a47ffa9843d8/Aviso+Urgente+de+Seguran%C3%A7a.pdf?MOD=AJPERES.
  • Reason
    Unexpected device authorization.
  • Action
    The company initiated the communication to the customers and plans to carry out the correction in the field (software update) of the equipment at a date not yet determined.

Device

Clinical Radiotherapy Linear Accelerator with 4DITC - version 10 and 11. Models at risk: Clinac 6...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Medical Systems Inc