medical Class II Updated 2021-01-13

Accuray Incorporated recalls TomoTherapy Treatment System - Product Usage: used as an int

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Codes: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468
View official government recall

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