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
    104970
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-21
  • 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
    Eclipse treatment planning system where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client worstation is not synchronized with the database / system server. when the eclipse client workstation clock is running behind the clock on the database/ system server it is possible that a change to the assigned hu value for a structure does not invalidate the density image stored in the cache and for the subsequent dose and monitor unit [mu] calculation to be based on the outdated hu assignment. the resultant mus may be higher or lower than expecteddependent on the specific hu assignments. treatment of the patient using these values can therefore lead to under - or over dose.

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
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.