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
    70181
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-12
  • Event Country
  • 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
    Software anomaly seen with eclipse electron monte carlo (emc) algorithm where no-equidistant data points in the open beam profile used during configuration may lead to inaccurate results. in a customer report seen (where no patients were involved) beam data collection with non-equidistant data points can lead to inaccurate dose distributions in the treatment plan. the sample dataset from the customer showed a 30% dose difference between the treatment plan isodose plot and the actual delivered dose.

Device

  • Model / Serial
    Model Catalog: 100042024 (Lot serial: >10 Serial Numbers.); Model Catalog: TPA001075000 (Lot serial: >10 Serial Numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.); Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: H484530); Model Catalog: TPA001094000 (Lot serial: H484531); Model Catalog: TPA001094000 (Lot serial: H484526); Model Catalog: TPA001094000 (Lot serial: H484527); Model Catalog: TPA001094000 (Lot serial: H484528); Model Catalog: TPA001094000 (Lot serial: H487506); Model Catalog: UP9001 (Lot serial: >10 Serial Numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.)
  • Product Description
    ECLIPSE TPS V8.8
  • Manufacturer

Manufacturer