Events

Safety Alert for Eclipse™ 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_20120320c.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 eclipse™ treatment planning system medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning eclipse™ treatment planning system, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0. according to varian, an anomaly has been identified with the eclipse™ treatment planning system where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. the issue may go unnoticed. proceeding to approve and treat with such a plan can result in the delivered dose distribution not matching the calculated dose distribution. 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

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

Manufacturer

Varian Medical Systems