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
    130306
  • 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
    An anomaly has been identified whereby following prolonged use the screw fastener holding the wedge body to the tray may fail. the falling wedge presents a risk of injury to patients or other personnel in the path of the falling wedge. the risk of failure is proportional to the amount of use of the wedge and is considered significant only after many years of use. the risk is also increased for heavier wedges upper wedges used in the interface mount and for wedges where the screw fasteners are loose or have a history of becoming loose. varian is aware of this occuring only for 30 degree upper wedges. other wedges may potentially be susceptible to the same failure.

Device

NOVALIS TX LINEAR ACCELERATOR
  • Model / Serial
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: (Lot serial: Contact Manufacturer.); Model Catalog: (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: Contact Manufacturer.)
  • Product Description
    NOVALIS TX LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.