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Accuray Incorporated recalls TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radi
Recalled January 13, 2021 · FDA recall Z-0784-2021 · Accuray Incorporated
Hazard
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. · FDA Class II
Units
7 units
Sold at
Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.
Description
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Product
TomoTherapy Treatment System - Product Usage: 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.
Manufacturer(s)
Accuray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →