Devices

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

Manufacturer

TomoTherapy Incorporated

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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