Events

Safety Alert for Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34)

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

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
    2011-11-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111117a.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 release 10 with aria™ radiation oncology (rt chart module) release 10 (client build 10.0.28 or build 10.0.34) medical device manufacturer, varian, has issued an urgent medical device correction concerning eclipse release 10 with aria™ radiation oncology (rt chart module) release 10 (client build 10.0.28 or build 10.0.34). an anomaly has been identified with eclipse and rt chart where adding a reference point in rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse. according to the local supplier, the affected device has been distributed in hong kong. the issue has been corrected in a maintenance release (10mr2, client build 10.0.39) of eclipse and rt chart. varian is notifying all possibly affected customers and to schedule installation of the corrected version. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0....
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian Eclipse Release 10 with ARIAT Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34)
  • Manufacturer
    Varian

Manufacturer

Varian