Events

Safety Alert for Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25 and 10.0.28)

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
    2011-10-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111018.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
    Urgent field safety notice: eclipse™ electron monte carlo (emc) release 6.5 thru 8.9 (dcs build 7.5.Xx thru 8.0.Xx and dcf build 8.1.Xx thru 8.9.17), and eclipse release 10.0 (dcf build 10.0.25 and 10.0.28) medical device manufacturer, varian medical systems, issued an urgent field safety notice concerning eclipse emc release 6.5 thru 8.9 and eclipse release 10.0, due to the configuration of the eclipse emc algorithm with non-equidistant data points in the open air profile may lead to inaccurate results, which may result in incorrect dose in the lateral direction. varian is sending a notification letter to remind users of the necessary actions. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for the corrective actions.

Device

Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF bu...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25 and 10.0.28)
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems