Events

Recall of OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM

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
    143971
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-07
  • 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 the ct localization module of the fastplan treatment planning system. if the module reports a significant different in tilt or spin on a slice (compared to the average of all slices) and the user elects to "discard" that slice an incorrect calculation of the isocenter location may result. the calculated ct localization volume can be incorrect when the "discard option is selected after a detection of a significant difference in tilt or spin for a particular slice. if this issue goes undetected the reported coordinates of the isocenter will be incorrect and a mistreatment could result.

Device

OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM
  • Model / Serial
    Model Catalog: 9701505A (Lot serial: HZ37010)
  • Product Description
    Optical Guidance Platform - FastPlan System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.