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
    73647
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-18
  • 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
    During dicom export of plan level images with a non square exported field of view (fov) an anomoly in the process of squaring the plan level image may cause the image to shift with respect to roi's and dose. when the anomoly occurs the magnitude of the image shift can be a full iec-x voxel a full iec-z voxel or full voxels in both iec-x and iec-z.

Device

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

Manufacturer

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