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
    26817
  • Event Risk Class
    II
  • Event Initiated Date
    2010-07-16
  • 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 the cosmetic linac cover (the 'nose' cover) is reattached to the linac after removal the rotating latches that secure the cover may not be properly engaged with the connection pins on the linac. if the latches are not fully engaged the linac cover can become loose and may unexpectedly drop off the linac. if a patient treatment is initiated while the cover is loose there is potential for it to contact the patient and lead to injury depending on the position and height of the linac at that time.

Device

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM - BASE CYBERKNIFE
  • Model / Serial
    Model Catalog: 030000 (Lot serial: C0202); Model Catalog: 030000 (Lot serial: C0231); Model Catalog: 032000 (Lot serial: C0231); Model Catalog: 032000 (Lot serial: C0202); Model Catalog: 028000 (Lot serial: C0231); Model Catalog: 028000 (Lot serial: C0202)
  • Product Description
    CyberKnife Robotic Radiosurgery System - Base CyberKnife
  • Manufacturer
    ACCURAY INC.

Manufacturer

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