TomoTherapy - Hi-Art Treatment System
by TomoTherapy


Conventional radiation treatment devices are at the end of an evolutionary path that began more than a century ago.
The TomoTherapy Hi·Art treatment system, in contrast, was designed in the 1990s. Our goal was to develop a machine that could turn advanced, optimized radiation treatment concepts into reality. Looks like a CT scanner because it is a CT scanner, allowing efficient 3D CT imaging to be used for ensuring the accuracy of treatment for every patient, every day. Leverages the ring gantry geometry used in CT scanning for the delivery of state-of-the-art, intensity-modulated radiation therapy (IMRT) from all angles around the patient. Was designed so that highly-precise treatment plans could result in more effective treatment deliveries, with minimized side effects for patients.
0RepliesFri Mar 18 2011 | Device Alert Manufacturer: TomoTherapy Europe GmbH [454116], Park Lane, Culliganlaan 2A, B-1831 Diegem, Belgium Problem: In a January 26, 2011, Field Safety Notice Medical Device Correction letter posted by the U.K. Medicines and Healthcare Product Regulatory Agency (MHRA), TomoTherapy states that it has received a report of an incident in which the delivered dose for a helical plan deviated from the dose indicated on the treatment planning station (TPS) and plan report. TomoTherapy states that this deviation occurred as targets became smaller in transverse width and farther from the axis of gantry rotation. This deviation was also observed to increase in inverse proportion to the actual modulation factor and steeper dose gradients in the target area. Delivery quality assurance (DQA) performed without dose scaling will detect this issue when present. TomoTherapy states that the specific effects observed on the target included a lower measured (delivered) peak dose and reduced dose coverage than that predicted by the TPS and that the TPS overpredicted the dose to the central region of small targets and the dose corresponding to a given percentage of the target volume covered. TomoTherapy states that the difference between planned and delivered dose was attributed to TPS models' helical delivery with 51 discrete stationary beams; however, the actual gantry motion during delivery is continuous, which results in "blurring" of the delivered dose relative to the dose predicted by the TPS for regions away from the axis of gantry rotation. Manufacturer/Regulatory Agency: Designation: TomoTherapy Reference No. 5089 MHRA Reference No. 2011/002/002/291/001 Action Needed: Verify that you have received the January 26, 2011, Field Safety Notice Medical Device Correction letter from TomoTherapy. Identify any affected product in your inventory. TomoTherapy recommends the following: (1) Use the information in the Field Safety Notice Medical Device Correction letter to avoid creating plans that are likely to contain discrepancies between planned and delivered doses. This includes the following: Check patient contours for target volumes that have small transverse diameters and are far from the axis of gantry rotation. When planning with high dose gradients, verify that the final modulation factor is >1.0. (2) When performing patient DQA point of interest dose measurements, specifically include measurements for small, off-axis targets that could be susceptible to this problem. (3) Perform DQA dose measurements at each unique full-fraction dose that will be used for patient treatment, without using DQA scaling. For example, if the patient plan contains two 10 Gy fractions, perform DQA dose measurement at the full 10 Gy, rather than scaling DQA dose down. Dose measurements may be conducted using a point dose detector such as an ionization chamber or by using film for which dosimetric validity at the original dose level has been established. TomoTherapy states that this problem will be corrected by changes to the dose calculation algorithm in a subsequent software release. Inform all relevant staff at your facility of the information in the letter. For Further Information: TomoTherapy technical solutions center (866) 368-4807 support@tomotherapy.comReply |
0RepliesMon Aug 16 2010 | Medical & Radiation Emitting Device Recalls [b]Date Posted[/b] August 02, 2010 [b]Recall Number[/b] Z-2115-2010 [b]Product[/b] 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. Code Information Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281. [b]Recalling Firm/Manufacturer:[/b] TomoTherapy Incorporated 1240 Deming Way Madison, Wisconsin 53717 [b]Consumer Instructions:[/b] Contact the recalling firm for information [b]Reason for Recall:[/b] In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. [b]Action:[/b] 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 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 email or telephone. [b]Quantity in Commerce[/b] 7 Distribution Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.Reply |
Manufacturer: TomoTherapy Europe GmbH [454116], Park Lane, Culliganlaan 2A, B-1831 Diegem, Belgium Problem: In a January 26, 2011, Field Safety Notice Medical Device Correction letter posted by the U.K. Medicines and Healthcare Product Regulatory Agency (MHRA), TomoTherapy states that it has received a report of an incident in which the del...
Date Posted> August 02, 2010 Recall Number> Z-2115-2010 Product> 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 ...