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
    86960
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-03
  • 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
    It has been identified that in certain configurations the 4ditc can interpret a rapidarc or vmat treatment field as 3d conformal arc treatment plan. if a rapidarc or vmat treatment field is incorrectly interpreted as conformal arc the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery which can lead to delivered dose being different than planned. this will only happen when the change in mu / deg between consecutive control points is small. in other words it can only happen when the dose rate or gantry speeds vary in a very smooth and progressive way for the entire rapidarc field. rapidarc treatment plans created with eclipse 8.2 and higher or potentially vmat treatment plans created with 3rd party treatment planning systems when delivered on the 4ditc v8.6 and v8.8 can be incorrectly identified as 3d conformal arc treatment plan.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Model / Serial
    Model Catalog: V8.6 (Lot serial: >10 serial numbers.); Model Catalog: V8.8 (Lot serial: >10 serial numbers.); Model Catalog: V8.6 (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.