Events

Recall of TOMOTHERAPY TREATMENT SYSTEM - KIT POWER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ACCURAY INCORPORATED.

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
    64899
  • Event Risk Class
    II
  • Event Initiated Date
    2010-12-28
  • 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
    Tomotherapy has discovered an anomaly during internal testing. if a tomodirect procedure which consists of 2 to 12 beam angles has an unrecoverable interrupt or emergency stop during a short time period between beam angles there is a small possibility that the procedure will indicate a "performed" status rather than "interrupted" on the operator station. if this occurs the user will not be able to generate a completion procedure. tomotherapy's investigation revealed that when an unrecoverable interrupt or emergency stop occurs with <1 second remaining in a tomodirect beam angle the logic in the software code checks if all the triggers (beam pulses) for the current beam angle is fully delivered and marks the procedure as "performed" rather than interrupted as intended. the anomaly is not taking into account if there are any remaining beam angles to be delivered.

Device

TOMOTHERAPY TREATMENT SYSTEM - KIT POWER
  • Model / Serial
    Model Catalog: 101264 (Lot serial: S/N: 10333); Model Catalog: 101264 (Lot serial: S/N: 10332)
  • Product Description
    TOMOTHERAPY TREATMENT SYSTEM - KIT POWER
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

ACCURAY INCORPORATED
  • Manufacturer Address
    MADISON
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    HC