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
    I1410-437
  • Event Number
    2009EBC-0004716
  • Date
    2014-10-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • 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 the sending of signals from the exacttrac to the treatment console can cause the unexpected removal of the interlocks of the equipment, causing the patient to be irradiated using a conical coil different from that established in the treatment planning, leading to deficiencies the treatments carried out on the patients.

Device

High and Low Energy Accelerators
  • Model / Serial
    CLINAC 6EX, CLINAC 600C, CLINAC IX, CLINAC 23EX, and TRILOGY
  • Product Description
    VARIAN model CLINAC high and low energy linear accelerators provide a conventional radiation therapy system or stereotactic radiosurgery for the management of lesions, tumors in any part of the body when radiation treatment is indicated, no diagnosis, no disease, but it provides a treatment for cancer.
  • Manufacturer
    Varian Medical Systems Beijing Co., Ltd

Manufacturer

Varian Medical Systems Beijing Co., Ltd