Events

Recall of Device Recall TomoTherapy HIART System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TomoTherapy 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
    56166
  • Event Risk Class
    Class 2
  • Event Number
    Z-2219-2010
  • Event Initiated Date
    2009-12-01
  • Event Date Posted
    2010-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92786
  • 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
    An issue was identified with the tomotherapy hi-art system. in the event a patient or dqa plan has a moved image, roll adjustments applied during registration will be incorrect. the planning station plan settings and dqa setup tabs allow for images to be moved during planning. during registration when roll is applied on moved images, the operator station incorrectly rolls the image about.
  • Action
    Consignee was sent a TomoTherapy "Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution.

Device

Device Recall TomoTherapy HIART System
  • Model / Serial
    110019
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    VA
  • Product Description
    Hi-Art System, H-0000-0003 || Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the 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 tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

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