Events

Recall of Device Recall CyberKnife System 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
    51550
  • Event Risk Class
    Class 2
  • Event Number
    Z-0908-2011
  • Event Initiated Date
    2009-03-16
  • Event Date Posted
    2011-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80674
  • 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
    The product has the potential for the extension coupling of the synchrony extension mounting hardware to become loose over time. the assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
  • Action
    Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail customersupport@accuracy.com to schedule service.

Device

Device Recall CyberKnife System Robotic Radiosurgery System
  • Model / Serial
    All units of these models.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan
  • Product Description
    CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA || A Radiation therapy device.
  • Manufacturer
    Accuray Inc

Manufacturer

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