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
    90044
  • 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 identified with the eclipse treatment planning system where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. this may go unnoticed. proceeding to approve and treat with such a plan can result in the delivered dose distribution not matching the calculated dose distribution. if a dose calculation or plan reload is performed while the compensator or fluence editor dialog is open the resultant dose distribution will be based on the compensator applied prior to edit. when the dialog box is subsequently closed the compensator will be updated. however the calculated dose distribution will not reflect the new compensator. use of the compensator for treatment will result in a dose different from the planned dose. if a verification plan is generated it will be based on the updated compensator such that the error is likely to go undetected.

Device

ECLIPSE TPS V8.8
  • Model / Serial
    Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001075000 (Lot serial: H482173); Model Catalog: 100042024 (Lot serial: >10 serial numbers.); Model Catalog: TPA001075000 (Lot serial: H481730); Model Catalog: UP9001 (Lot serial: Contact manufacturer.); Model Catalog: UP9001 (Lot serial: >10 serial numbers.)
  • Product Description
    ECLIPSE Treatment Planning System V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.