Events

Safety Alert for Elekta linear accelerator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Elekta Limited || Elekta Instrument Ab.

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
    A1701-14
  • Event Number
    2009EBC-0005074
  • Date
    2017-01-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=106
  • 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 reports that if the tc data contains cuts that occur at the xx, x50 mm positions, there may be parts of the volume where there is a mismatch between the contour graphs on the screen and the contour data used during the optimization and the calculation of the dose, which could lead to potentially adverse events on the patient due to dose administration and incorrect treatments.

Device

Elekta linear accelerator
  • Model / Serial
    AXESSE, PRECISE and INFINITY, MONACO v5.0 software version and those that import data from TC cuts with || Z DICOM coordinates in xx, x50 mm, specific serials.
  • Product Description
    This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved.
  • Manufacturer
    Elekta Limited || Elekta Instrument Ab

Manufacturer

Elekta Limited || Elekta Instrument Ab
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NIDFSINVIMA