Events

Safety Alert for radiosurgery equipment Elekta

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
    I1410-412
  • Event Number
    2009EBC-0005038
  • Date
    2014-10-17
  • 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 coordinate system to be aligned with the adapter frame of the previous systems may experience a movement of the lens up to 0.5mm from the intended position, since the block flanges may cause the frame to be poorly closed preventing the coordinate frame from it is fixed properly, causing a small mechanical mismatch between the decoded system and the frame adapter in the z direction, which can lead to possible adverse events on the patients.

Device

radiosurgery equipment Elekta
  • Model / Serial
    LEKSELL GAMMA KNIFE, serials FV001 up to FV376
  • Product Description
    Radiosurgery system for the use in stereotactic radiation of intracranial structures. Surgery is continued by providing a prescribed dose in the form of one or more shots of ionizing radiation directed at the target site. During radiation there are no moving parts inside the unit and therefore, safety, stability and precision are inherent characteristics
  • Manufacturer
    Elekta Instrument AB

Manufacturer

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