Events

Recall of Device Recall CyberKnife Robotic Radiosurgery System

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    52643
  • Event Risk Class
    Class 2
  • Event Number
    Z-1810-2009
  • Event Initiated Date
    2009-06-22
  • Event Date Posted
    2009-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83540
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Targeting accuracy out of specification, error alert does not render the system down, which may result in mistreatment in the wrong area.
  • Action
    Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue. For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.

Device

Device Recall CyberKnife Robotic Radiosurgery System
  • Model / Serial
    All system Serial Numbers C128 and higher with 2005 edition Robot Controller.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.
  • Product Description
    CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. || Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Accuray Inc

Manufacturer

Accuray Inc
  • Manufacturer Address
    Accuray Inc, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Source
    USFDA