Events

Safety Alert for Patient Positioning System Guided by Image

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Brainlab AG.

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
    I1406-236
  • Event Number
    2013EBC-0010225
  • Date
    2014-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=202
  • 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 affirms that when using radiography, correction and control after fusion on the basis of bone structures, the system can show images of the patient previously loaded and not the digitally reconstructed radiographic image, causing operator confusion due to the change of images and possible incorrect calculations, leading to that potentially adverse events occur on the patient.

Device

Patient Positioning System Guided by Image
  • Model / Serial
    EXACTRAC VERO, software version: v.3.0.0, 3.1.0, 3.1.1, 3.2.0 and 3.2.1
  • Product Description
    It has been designed to place the patient at a defined point in the treatment beam emitted by a medical linear accelerator for the performance of radiotherapy stereotactic radiotherapy treatments for the treatment of lesions, tumors and other indications of any part of the body that require the application of radiation. EXACTRAC can also be used to monitor the patient's position during treatment.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    NIDFSINVIMA