Events

Field Safety Notices about On-Board Imager® with CBCT

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 Varian Medical Systems.

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
    2016-02-08
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • 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
    Varian has received several reports of the on-board imager® cone beam ct [cbct] acquisition stalling preventing reconstruction of the image. a repeat scan will be required. there are two possible symptoms. 1) the cbct application stops updating the display during acquisition. 2) an exception occurs during the acquisition. although cbct projections will have been acquired, it will not be possible to generate the reconstructed cbct and the scan must be repeated. there have been no misadministration or injuries reported due to this issue. .

Device

On-Board Imager® with CBCT

Manufacturer

Varian Medical Systems