Events

Recall of Device Recall RoboCouch Patient Positioning 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
    64809
  • Event Risk Class
    Class 2
  • Event Number
    Z-1155-2013
  • Event Initiated Date
    2013-03-27
  • Event Date Posted
    2013-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117112
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • Reason
    A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the robocouch manipulator may be defective.
  • Action
    Accuray issued an Urgent Advisory Notification letter dated March 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Field Service Engineers will be replacing the affected product. Questions and concerns are to be directed to Accuray Customer Support at 1-877-668-8667

Device

Device Recall RoboCouch Patient Positioning System
  • Model / Serial
    Model number: 025007
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.
  • Product Description
    RoboCouch Patient Positioning System || Product Usage: is 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 Incorporated

Manufacturer

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