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
    22909
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-21
  • 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
    Using the rt chart function in aria versions 8.0 and 8.1 when users select the "convert to set-up field" option a set-up field is created that removes the dmlc (dynamic multi leaf collimator) plan components in order to create an open collimator for field light setup purposes. in a recently reported case a user having selected this option in error then converted the set- up field back to a treatment field. the resulting treatment field is then missing the dmlc. if this error is not detected prior to patient treatment open field treatment can result.

Device

ARIA SOFTWARE
  • Model / Serial
    Model Catalog: (Lot serial: HIT2414M); Model Catalog: (Lot serial: HIT0606M); Model Catalog: (Lot serial: HIT0040); Model Catalog: (Lot serial: HIT2414R1); Model Catalog: (Lot serial: HIT0606R1)
  • Product Description
    ARIA SOFTWARE
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.