Events

Recall of ECLIPSE TPS V13.6

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
    36629
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-14
  • 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 was identified with eclipse treatment planning system using pencil beam convolution (pbc) 11.0.31 to compute a conventional arc dose distribution. when using pbc 11.0.31 to calculate the does for a conventional arc field with more than 100 segments with eclipse versions 11.0 13.0 13.5 or 13.6 the displayed dose does not correspond to the calculated monitor units (mu). all affected devices in canada are at version 11.0.

Device

ECLIPSE TPS V13.6
  • Model / Serial
    Model Catalog: (Lot serial: none); Model Catalog: VERSION 13.5 (Lot serial: none); Model Catalog: VERSION 13 (Lot serial: none); Model Catalog: TPC001001001 (Lot serial: none)
  • Product Description
    Eclipse TPS version 13.6
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.