Home / Recalls / Medical Devices
TomoTherapy Incorporated recalls TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art
Recalled August 27, 2014 · FDA recall Z-2240-2014 · TomoTherapy Incorporated
Hazard
Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions. · FDA Class II
Units
168 (75 US; 93 OUS)
Sold at
Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA, BELGIUM, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILIPPINES, RUSSIA, SPAIN, TAIWAN, TURKEY, MARTINIQUE, ROMANIA, SRI LANKA and SWITZERLAND.
Description
Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.
Product
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment 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 tissues. 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 physicians prescribed and approved plan.
Manufacturer(s)
TomoTherapy Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →