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
    A1609-382
  • Event Number
    2009EBC-0005074
  • Date
    2016-09-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 has determined that in a specific workflow in which the contours are modified (expanded, moved, copied, etc.) and then the contour of some cuts is deleted and saved in the same session, it is it is possible that the deleted contours are still present, even though the planner would like to eliminate them, which could lead to the potential occurrence of adverse events on the patient due to administration of incorrect doses and treatments.

Device

Elekta linear accelerator
  • Model / Serial
    AXESSE, SYNERGY and INFINITY, MONACO software version v3.1 and later, 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