Events

Recall Or Safety Alert for ExacTrac Radiographic Patient Positioning and Verification System with accessories and consumables

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by BrainLAB AG, GERMANY.

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
    Recall / Safety alert
  • Event Number
    ИМ-7.96829
  • Date
    2014-04-03
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Extra notes in the data
  • Reason
    The manufacturer found that when using several isocenters (several radiation therapy goals) within one manipulation, the exactrac patient positioning and verification system with the exactrac v6.0.3 software version can position the patient in the wrong isocenter position. brainlab asks end users to avoid using multiple isocenters during treatment. if treatment with several isocenters cannot be avoided, it is necessary to close the exactrac program after treatment of the patient using one isocenter and restart the treatment plan before choosing the next isocentre. to solve this problem, brainlab is planning to release a software update.

Device

ExacTrac Radiographic Patient Positioning and Verification System with accessories and consumables

Manufacturer

BrainLAB AG, GERMANY