Events

Recall of Device Recall TomoTherapy HiArt System, ver. 4.0.0, 4.0.1, 4.0.2.

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
    56056
  • Event Risk Class
    Class 2
  • Event Number
    Z-2072-2010
  • Event Initiated Date
    2010-06-23
  • Event Date Posted
    2010-07-22
  • 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=92555
  • 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
    An issue has been identified, as a result of input received from one tomotherapy hi-art treatment system customer. with a particular workflow, the planning station's draft and/or final plan report can provide incorrect dose statistics.
  • Action
    Consignees were sent on 6/23/10 a TomoTherapy "Urgent Field Safety Notice Medical device Correction" letter dated June 22, 1010. The letter addressed the Issue, Product Affected, Recommended Action and Resolution. Prior to generating a draft or final Plan Report for a given plan, the plan must be closed and reopened at least once. This issue will be remedied by Hi-Art software version 4.0.3, scheduled for release in late 2010. Customers with questions were provided with a contact in the letter at the TomoTherapy Customer Interaction Center. The firm can be contacted at 608-824-2800.

Device

Device Recall TomoTherapy HiArt System, ver. 4.0.0, 4.0.1, 4.0.2.
  • Model / Serial
    Serial #'s:  110019, 110083, 110169, 110284, 110305, 110312, 110034, 110091, 110174, 110285, 110306, 110314, 110037, 110092, 110278, 110288, 110308, 110316, 110056, 110150, 110281, 110293, 110309, 110318, 110065, 110159, 110283, 110300, 110311
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.
  • Product Description
    TomoTherapy Hi-Art System¿, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System¿ is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation 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