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
    94139
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-17
  • 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
    When multiple conical collimator treatment plans are scheduled to be treated in a session the plan label should be displayed on the bccv dialog box should match the plan label on the 4ditc. however the name of the plan is not being updated correctly. all other identifiers including the accessory mount (conical collimator) are correct and are displayed correctly. a report was received involving the 4d integrated treatment console (4ditc) and bar - code conical collimator (bccv) indicating that the plan label is not updated correctly in bccv display if multiple plans are open in 4ditc simulatenously.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Model / Serial
    Model Catalog: V8.8 (Lot serial: H513769); Model Catalog: BCCV (Lot serial: HBC0210); Model Catalog: BCCV (Lot serial: HBC0028); Model Catalog: V8.8 (Lot serial: H515461)
  • Product Description
    ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.