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
    I1609-401
  • Event Number
    2009EBC-0005074
  • Date
    2016-09-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 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 when a plan3d of monaco is exported through dicom and the check box "composite field sequencing" (cfs, [field composition sequencing]) is selected, the jaws y are set to the shape of the port, despite that they should continue how and where they were defined. this fact takes place when the shape of the port used to define or edit the positions of the mlc extends beyond or within the actual positions of the jaws, the problem is when a workflow is used for the imrt with direct planning involving the creation of several you do for the same gantry angle with a single mlc shape defined for each beam, these beams then see the cfs to combine the individual 3d beams into a single sequence of imrt beams, leading to an overdosage or receive less than necessary, which could potentially cause the presentation of adverse events on the patient.

Device

Elekta linear accelerator
  • Model / Serial
    AXESSE, SYNERGY and INFINITY, MONACO software version v5.11 and 5.20, 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