Events

Recall of ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)

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
    102599
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-13
  • 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
    Multiple isocenter plans will load on the 4 ditc and are available for imaging and treatment but the 4ditc software does not recognize that multiple isocenters are present. acquired couch parameters can be applied to any or all fields in the treatment plan regardless of isocenter definition. this involves product versions 7.029 8.1.1.3 8.1.38.1.4.0 8.3.0.12 8.6.1 8.6.2.0 8.8.1.7.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Model / Serial
    Model Catalog: V8.8 (Lot serial: >10 units.); Model Catalog: V8.6 (Lot serial: >10 units.); Model Catalog: V8.1.2 (Lot serial: >10 units.); Model Catalog: V8.6 (Lot serial: Contact manufacturer.); Model Catalog: V8.1.2 (Lot serial: Contact manufacturer.); Model Catalog: V8.8 (Lot serial: Contact manufacturer.)
  • Product Description
    Aria Practice Management -4D Integrated Treatment Console (4DITC)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.