Device Recall TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.

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.