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
    81800
  • Event Risk Class
    II
  • Event Initiated Date
    2010-01-27
  • 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
    When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam on the plan were not updated by the system. these depths were incorrect and led to an incorrect dose calculation. the erroneous dose was not delivered to the patient therefore serious injury did not occur.

Device

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM - BASE CYBERKNIFE
  • Model / Serial
    Model Catalog: SOFTWARE VERSION 3.1 (Lot serial: C202); Model Catalog: SOFTWARE VERSION 3.0 (Lot serial: C202); Model Catalog: SOFTWARE VERSION 3.5.0 (Lot serial: C202); Model Catalog: SOFTWARE VERSION 3.5.1 (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