Events

Recall of Device Recall CyberKnife Robotic Radiosurgery System Device

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
    54658
  • Event Risk Class
    Class 2
  • Event Number
    Z-1023-2011
  • Event Initiated Date
    2010-01-15
  • Event Date Posted
    2011-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88954
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. these depths were incorrect and led to an incorrect dose calculation. software patch /update to address this issue. implementation at affected sites will initiate, once the patch is available.
  • Action
    The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated January 18, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to load the plan and recalculate the dose to reflect the current state of beam, compare the reloaded plan and the recalculated plan to verify maximum dose and prescription values, and re-prescribe and save to overwrite to existing plan if necessary. The firm is developing a patch/software update to address the issue and a Accuray Customer Support person will contact the customer regarding further resolutions. If you have any questions or concerns regarding this issue, contact Accuray Customer Support at +1-877-668-8667(USA) or +1-408-716-4700 (non USA) or email: customersupport@accuray.com.

Device

Device Recall CyberKnife Robotic Radiosurgery System Device
  • Model / Serial
    Item Number : 025000. Serial Number: C0150. Model numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.50, and 3.5.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong.
  • Product Description
    Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. || For the treatment planning and image guided 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