FDA Device

ThomoTherapy Hi-Art System 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.

Hazard

TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.

What You Should Do

Remedy

Consignees were sent a TomoTherapy "Urgent Field Safety Notice" dated November 8, 2010. The letter addressed to TomoTherapy Customers described the Issue, Product Affected, Recommended Action and Resolution. Customers are to contact the TomoTherapy Customer Interaction Center for further instruction and assistance in generating a completion procedure, if they experience the issue. Questions should be directed towards the TomoTherapy Customer Interaction Center via email or telephone.

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Products

ThomoTherapy Hi-Art System 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
Brand
TomoTherapy Incorporated
UPC
Serial #'s  110019 110254 110299 110327 110024 110271 110300 110328 110051 110277 110303 110329 110056 110278 110308 110330 110091 110281 110309 110332 110092 110283 110310 110333 110174 110284 110311 110335 110202 110285 110313 110336 110243 110288 110318 110337 110251 110293 110326, and 110339.

Units Affected

40 (21US; 19 OUS)

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