Events

Recall of Device Recall RoboCouch Patient Support System, a subsystem of the 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
    53047
  • Event Risk Class
    Class 2
  • Event Number
    Z-0853-2011
  • Event Initiated Date
    2009-07-21
  • Event Date Posted
    2011-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84538
  • 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
    Powered Radiation Therapy Couch - Product Code JAI
  • Reason
    Mechanical failure-- patient support system's table top may unexpectedly descend several inches.
  • Action
    Consignees were notified verbally about the issue when an inspection was scheduled.

Device

Device Recall RoboCouch Patient Support System, a subsystem of the Cyberknife Robotic Radiosurge...
  • Model / Serial
    RoboCouch model 025007
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.
  • Product Description
    RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. || Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
  • Manufacturer
    Accuray Inc

Manufacturer

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