Events

Safety Alert for Treatment planning system

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 Imaging Laboratory Gmbh || 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
    I1602-54
  • Event Number
    2009EBC-0004720
  • Date
    2016-02-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=157
  • 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 states that it has identified anomalies in the field dose calculation of conventional arc therapy (arcotherapy), leading to the possible occurrence of adverse events or delays in patient care.

Device

Treatment planning system
  • Model / Serial
    Software versions 11, 13.0, 13.5 and 13.6, with Pencil Beam Convolution algorithm 11.0.31.
  • Product Description
    Indicated in radiotherapy in applications for cancer treatment. Used in external or internal beam planning of radiation treatments for patients with known physiological conditions to cope with the radiation of therapeutic photons beams, electron beam, proton beams or radioisotopes.
  • Manufacturer
    Varian Medical Systems Imaging Laboratory Gmbh || Varian Medical Systems, Inc

Manufacturer

Varian Medical Systems Imaging Laboratory Gmbh || Varian Medical Systems, Inc