Events

Safety Alert for Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0

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
    2012-03-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120307b.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: eclipse treatment planning system, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0 medical device manufacturer, varian medical systems, has issued a field safety notice concerning eclipse treatment planning system, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0. according to varian, an anomaly has been identified with the eclipse treatment planning system (in both external beam planning and irreg tasks) when planning for the machines that have multileaf collimator (mlc) device replacing upper and/or lower collimator jaws. for these machines modeled with ‘virtual jaws’ (refer to“collimator jaws” replaced by mlc) , positioning a virtual jaw inside the mlc aperture will result in an incorrect dose distribution within eclipse. varian is identifying possible technical solutions for this issue. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems