TomoTherapy Treatment Delivery System with iDMS - 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.

Reason: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

Code information: Product Codes: 104430, 1018286, H-0000-0003, 1018283. System Version: 1.2 (also referred to as 5.6.2). Serial Numbers: 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368,

Distribution pattern: 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.