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
    18923
  • Event Risk Class
    I
  • Event Initiated Date
    2010-11-02
  • 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
    The exact couch and exact targeting couch for clinac or acuity units has the potential to trap a finger that could lead to loss of digit although some of the trapping zones (or pinch points) presented risks to lower extremities.

Device

NOVALIS TX LINEAR ACCELERATOR
  • Model / Serial
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: EX (Lot serial: H770414); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294553); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: EX (Lot serial: H770306); Model Catalog: EX (Lot serial: H770245); Model Catalog: EX (Lot serial: H770233); Model Catalog: EX (Lot serial: H770184); Model Catalog: EX (Lot serial: H770166); Model Catalog: EX (Lot serial: H770347); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial #s.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: Contact manufacturer.); Model Catalog: 600N (Lot serial: >10 seria
  • Product Classification
    Hematology and Pathology Devices
  • Product Description
    Novalis TX Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.