Events

Recall of Device Recall TomoH(R) 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
    78686
  • Event Risk Class
    Class 2
  • Event Number
    Z-0288-2018
  • Event Initiated Date
    2017-11-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160117
  • 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
    Uncontrolled couch z-axis movement (descent).
  • Action
    Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated the following: "Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem." For questions contact Accuray Customer Support by phoning the regional support lines.

Device

Device Recall TomoH(R) System
  • Model / Serial
    Serial Numbers: 110040 110083 110163 110231 110237 110289 110302 110369 110418 110461 110462 110474 110491 110494 110503 110519 110525 110533 110536 110537 110552 110554 110556 110562 110565 110570 110573 110576 110577
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    TomoH(R) System, Model Number 1018284 || Product Usage: || The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • Manufacturer Address
    Accuray Incorporated, 1240 Deming Way, Madison WI 53717-1954
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    USFDA