Events

Safety Alert for Precise 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
    I1410-409
  • Event Number
    2009EBC-0005074
  • Date
    2014-10-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=194
  • 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 the tables of the previous equipment may present a position error if the deposition sensors are not installed correctly during the corrective maintenance, the system has a software check to find large position errors, but the table can be placed with a margin of error > 5 mm without showing any warning, which can lead to possible adverse events on patients.

Device

Precise linear accelerator
  • Model / Serial
    PRECISE Treatment Table, 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 Instrument AB

Manufacturer

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