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
    19938
  • Event Risk Class
    II
  • Event Initiated Date
    2010-05-06
  • 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
    Note: series date parameter is optional and not found on all systems. mr misalignment in cone planning could be consistently encountered on any datasets where mr data has an empty (0008 0021) series date dicom element. while the mr image could be correctly fused with a corresponding ct dataset fusion results will be incorrectly loaded into fastplan's cone planning if an empty series date data field is encountered. no warning or error message is produced. any resulting large misalignment should be obvious if the blended ct-mr view is selected since the isocenter will be misplaced on the 3d view and trace contour views. in the worst case scenario however if you use the default mr- only view settings perform planning on mr only and do not notice isocenter misplacement on the 3d view or on contour tracing slides this could lead to a significant mis-alignment of the plan.

Device

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

Manufacturer

VARIAN MEDICAL SYSTEMS INC.