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
    42986
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-29
  • 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
    Under certain specific circumstances the gantry rotates in the opposite direction to that specified according to the plan parameters when moving from one field to the next. if the patient couch or other medical equipment isi n the path of the gantry damage to property or injury to a patient could occur. according to varian iec scale the gantry will rotate clockwise (cw) from 0.0 degrees to 180.0 degrees and counterclockwise from 0.0 degrees to 180.0e degrees. by default when a user creates an opposing field within a plan that contains static fields the gantry rotation is set to rotate in the clockwise direction. for situations when that is not desired a user activated extended angle flag is provided to cause the gantry to rotate in a counterclockwise direction.

Device

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

Manufacturer

VARIAN MEDICAL SYSTEMS INC.