Events

Safety Alert for FastPlan treatment planning system

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

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
    2012-03-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120320b.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 fastplan treatment planning system medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning fastplan treatment planning system. according to varian, an anomaly has been identified with the ct localization module of the fastplan treatment planning system. if the module reports a significant difference in tilt or spin on a slice (compared to the average of all slices) and the user elects to “discard” that slice, an incorrect calculation of the isocenter location may result. if this issue goes undetected, the reported coordinates of the isocenter will be incorrect and a mistreatment could result. varian is notifying all possibly affected customers with a field safety notice. according to varian, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

FastPlan treatment planning system
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian Eclipse™ Treatment Planning System
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems