Devices

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

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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