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
    27320
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-16
  • 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
    An anomaly has been identified with varian eclipse treatment planning system and aria radiation oncology (rt chart application) where adding a reference point in aria rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse. a reference point added in aria rt chart does not have a location and is sometimes referred to as a "dose prescription volume" or dpv. if a reference point without location or dpv is added in aria rt chart and the field dose contribution of the reference point is edited this may cause the dose per fraction and total prescribed dose of an unapproved treatment plan in eclipse to change. this anomaly can occur when there is plan normalization such that the total done and the total dose at primary have different values.

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.