Events

Recall of Device Recall TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.

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
    56052
  • Event Risk Class
    Class 2
  • Event Number
    Z-2115-2010
  • Event Initiated Date
    2010-02-22
  • Event Date Posted
    2010-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92546
  • 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
    Radiation Therapy System - Product Code MUJ
  • Reason
    In some cases, the patient's diagnostic ct image is narrower than the hi-art radiotherapy couch image.
  • Action
    Consignees were sent on 2/22/10 a TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated Monday, February 22, 2010. The letter was addressed to TomoTherapy Customer and identified the the affected product, and included a description of the Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoTherapy Customer Interaction Center by e-mail or telephone.

Device

Device Recall TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.
  • Model / Serial
    Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
  • Product Description
    TomoTherapy Hi-Art System¿, Version 4.0.0 & 4.0.1. || TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. || Intended to be used as an integrated system for 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.
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

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