Field Safety Notices about ExacTrac 6.0

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Brainlab.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
  • Event Country
  • Event Source
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    When uploading and processing extensive treatment plans, e.G. with a large amount of imaging and a high number of outlines, there may be an error in exactrac's internal graphics memory. such memory failure may, under certain conditions, cause the exactrac system to display digitally reconstructed x-ray (drr) data of a previously loaded patient data set instead of a correct drr during the course of patient placement work on all subsequent open patient treatment plans until exactrac is restarted.