Events

Safety Alert for TrueBeam and TrueBeam STx

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Varian.

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
  • Date
    2011-11-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111108.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: varian truebeam and truebeam stx medical device manufacturer, varian, has issued an urgent medical device correction concerning truebeam and truebeam stx. it has been identified with the truebeam and truebeam stx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape. the presence of this elongated beam spot shape can be detected by a larger than expected difference in the penumbra between the radial and transverse planes, as measured by beam profile scans. varian is notifying all possibly affected customers with the notice and developing a correction for this issue. according to the local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

TrueBeam and TrueBeam STx
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian TrueBeam and TrueBeam STx
  • Manufacturer
    Varian

Manufacturer

Varian