Events

Safety Alert for Eclipse Treatment Planning System: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), Model: H48

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

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
    2011-07-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110708.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: eclipse release 6.5 through 10 (versions 7.3.10 to 10.0.34), model: h48 it has come to our attention that varian medical systems, inc. has issued a global field safety notice to customers regarding the captioned planning system used in radiotherapy treatments.  according to the manufacturer, hong kong is affected. in affected eclipse versions, user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. varian is preparing a maintenance release (service pack) of eclipse software to address the problem. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Eclipse Treatment Planning System: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), M...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), Model
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.