Events

Recall of CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM - IRIS COLLIMATOR

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
    53439
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-19
  • 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
    A supplier found and reported that some of their connector blocks were out-of specification. the defect on the master - side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings and as a result the tilt may cause a potential change to the central axis of the radiation beam. this could affect a system in the event that a connector block was replaced after the last beam alignment check for the fixed collimator housing and iris variable aperture collimator.

Device

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM - IRIS COLLIMATOR
  • Model / Serial
    Model Catalog: 027739 (Lot serial: C0202); Model Catalog: 029829 (Lot serial: C0202); Model Catalog: 027739 (Lot serial: C0238); Model Catalog: 029829 (Lot serial: C0238); Model Catalog: 027739 (Lot serial: C0231); Model Catalog: 029829 (Lot serial: C0231)
  • Product Description
    Cyberknife Robotic Radiosurgery System-Iris Variable Aperture Collimator
  • Manufacturer
    ACCURAY INC.

Manufacturer

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