Events

Recall of ARIA SOFTWARE

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
    72386
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-14
  • 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 in the aria versions 8.0 and 8.1 when an image sequence template is added to a field in rt chart and a ciao (completely irradiated aperture opening) is calculated the resulting ciao display at 4ditc may be wrong. this results in a ciao which is in many cases larger than the actual largest extent of the irradiated area - possibly leading to an unintentional gap if that outline is used for edge matching of a second field.

Device

ARIA SOFTWARE
  • Model / Serial
    Model Catalog: VISION (VERSION 6.5) (Lot serial: HIT0716); Model Catalog: VISION (VERSION 6.5) (Lot serial: HIT0040); Model Catalog: VISION (VERSION 6.5) (Lot serial: HIT0606M); Model Catalog: VISION (VERSION 6.5) (Lot serial: HIT0606RI)
  • Product Description
    Aria Software (Version 6.5)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.