Events

Recall of CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM - BASE CYBERKNIFE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ACCURAY 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
    36560
  • Event Risk Class
    II
  • Event Initiated Date
    2010-01-08
  • 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
    As part of commissioning the treatment planning system the user is required to obtain and enter the ct number to relative electron density and ct number to mass density calibration curves for a given ct scanner. if the electron density values are empty the calculation of radiation dose in the patient will be modeled as air - like density material rather than the correct density. by using this incorrect model plans saved and created as deliverable will display a radiation dose that is incorrect.

Device

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM - BASE CYBERKNIFE
  • Model / Serial
    Model Catalog: 030000 (Lot serial: C202)
  • Product Description
    CyberKnife Robotic Radiosurgery System
  • Manufacturer
    ACCURAY INC.

Manufacturer

ACCURAY INC.
  • Manufacturer Address
    SUNNYVALE
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    HC