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
    21346
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-28
  • 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
    It was discovered that a patient received grade 3 dermatitis in the contralateral axilla. it was determined the user did not include the contralateral axilla during evaluation of the treatment plan. as a result dose to this region was unaccounted for and ultimately delivered leading to grade 3 dermatitis.

Device

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM - BASE CYBERKNIFE
  • Model / Serial
    Model Catalog: 030000 (Lot serial: C0238); Model Catalog: 028000 (Lot serial: C0231); Model Catalog: 030000 (Lot serial: C0231); Model Catalog: 032000 (Lot serial: C0202); Model Catalog: 030000 (Lot serial: C0202); Model Catalog: 028000 (Lot serial: C0202); Model Catalog: 032000 (Lot serial: C0238); Model Catalog: 028000 (Lot serial: C0238); Model Catalog: 032000 (Lot serial: C0231)
  • Product Description
    CyberKnife Robotic Radiosurgery System - Base CyberKnife (028000 030000 032000)
  • Manufacturer
    ACCURAY INC.

Manufacturer

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