Events

Recall of ECLIPSE TPS V8.8

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VARIAN MEDICAL SYSTEMS INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79362
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The energy shown or selected by the treatment planner in the 'fields' tab of the external beam planning (ebp) and in the 'general' tab of field properties may differ from the value actually used for dose calculation. caused by incorrect handling of the energy mode object within the memory cache system used by eclipse external beam planning version 10. when the user changes field energy the memory cache anomaly may result in use of previously selected field energy instead of intended field energy. this cache memory issue may arise when switching between software applications (such as between external beam planning and rt chart) when using multiple sessions or when switching between patients in a single session of ebp in eclipse.

Device

ECLIPSE TPS V8.8
  • Model / Serial
    Model Catalog: 100042024 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: 100042024 (Lot serial: CONTACT MANUFACTURER.)
  • Product Description
    Eclipse Treatment Planning System V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.