Events

Recall of NOVALIS TX LINEAR ACCELERATOR

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
    90596
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-28
  • 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
    Rapid arc and vvmat treatment may deliver as dynamic arc on incorrectly configured system. under these circumstances dynamic dose rate and gantry speed features as well as avoidance sectors (range of gantry rotation where no dose should be delivered) that may be part of a vmat plan are not recognized and dose delivered does not match the treatment plan.

Device

NOVALIS TX LINEAR ACCELERATOR
  • Model / Serial
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: H272309); Model Catalog: 21EX (Lot serial: H272216); Model Catalog: 21EX (Lot serial: H272158); Model Catalog: 21EX (Lot serial: H272157); Model Catalog: 21EX (Lot serial: H272910); Model Catalog: 21EX (Lot serial: H271926); Model Catalog: 21EX (Lot serial: H271663); Model Catalog: 21EX (Lot serial: H271662); Model Catalog: 21EX (Lot serial: H272310); Model Catalog: 21EX (Lot serial: H271941)
  • Product Description
    Novalis TX Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.