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 Incorporated.

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
    75863
  • Event Risk Class
    Class 2
  • Event Number
    Z-0734-2017
  • Event Initiated Date
    2016-11-22
  • Event Date Posted
    2016-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151477
  • 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
    Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. this issue is limited to certain cyberknife¿ systems with software version 1 0.6.
  • Action
    Accuray sent an Urgent Safety Advisory Notification letter dated November 22, 2016, to all affected customers. Letters alerted users to the issue and the sequence of events necessary for it to occur. Accuray reps will visit all sites to perform a software upgrade to correct the issue. For more information or any questions about this notification, please contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support. For further questions, please call (408) 716-4600.

Device

Device Recall CyberKnife Robotic Radiosurgery System
  • Model / Serial
    Catalog/Part Number: 54000 manufacturing or serial number of UDI: M658053301 0; Serial numbers:  C0330 C0334 C0336 C0338 C0342 C0344 C0348 C0349 C0351 C0358 C0359 C0360 C0361 C0363 C0364 C0366 C0367 C0370 C0372 C0376 C0387 C0389 C0390 C0391 C0393 C0394 C0395 C0396 C0397 C0398 C0400 C0402 C0404 C0406 C0407 C0408 C0409 C0410 C0413 C0414
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey
  • Product Description
    CyberKnife Robotic Radiosurgery System using software version 10.6; || Catalog/Part Number: 54000 || UDI: M658053301 0 || Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when || radiation treatment is indicated.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • Manufacturer Address
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    USFDA