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 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
    I1509-440
  • Event Number
    2009EBC-0005037
  • Date
    2015-09-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=170
  • 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 the user establishes a maximum field size for each filter, this is not stipulated by the software when the fixed filters and mlc are present in the column, therefore the calculation is incorrect and the administration of the dose is out of the physical area of the filter, resulting in that the dose of distribution calculated by the software does not coincide with the dose administered, which could lead to the potential occurrence of adverse events on the patient.

Device

Elekta linear accelerator
  • Model / Serial
    XIO software, version 4.51 and later.
  • Product Description
    Integrated system to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved
  • Manufacturer
    Elekta Instrument Ab

Manufacturer

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