Device Recall TomoTherapy HiArt System

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Radiology Devices

2

No

Worldwide Distribution-- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and the countries United Arab Emirates United Kingdom Turkey Switzerland Sweden Spain Saudi Arabia Poland Netherlands Italy Germany France Belgium Taiwan Singapore Malaysia Korea Japan India Hong Kong China Australia Mexico El Salvador and Canada

Hi¿Art versions 4.0.x, and HD versions 1.0.x, H-0000-0003. || The TomoTherapy HI-ART System is intended to be used as an integrated system for the 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. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281.

Radiology Devices

2

No

Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.

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.

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

Radiology Devices

2

No

CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.

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.

110019

Radiology Devices

2

No

VA

Hi-Art System, H-0000-0003 || Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the 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. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan