Events

Safety Alert for High and Low Energy Accelerators

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Varian Medical Systems Beijing Co., Ltd.

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
    I1402-91
  • Event Number
    INVIMA 2009EBC-0004716
  • Date
    2014-02-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=208
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that there have been differences between the real physical positions and the reading made by the equipment of the table and the table, due to the fact that the connection lines have a very high resistance, providing differences in the reference voltages to the spatial deposition potentiometers, leading to that potential adverse events are presented to the patient or the user.

Device

High and Low Energy Accelerators
  • Model / Serial
    CLINAC IX, NOVALIS, TRILOGY and UNIQUE
  • Product Description
    VARIAN linear and high-energy accelerators CLINAC model provide a conventional radiotherapy or stereotactic radiosurgery system for the management of injuries, tumors in any part of the body when seindicate a radiation treatment, does not diagnose any disease but provides a treatment for cancer.
  • Manufacturer
    Varian Medical Systems Beijing Co., Ltd

Manufacturer

Varian Medical Systems Beijing Co., Ltd