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
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
What You Should Do
Remedy
Urgent Medical Device Recall "MLC tickle error" issue during TomoHelical deliver was sent to customers beginning 12/10/2020. Accuray is planning software releases that will address this issue. All TomoTherapy systems at affected software versions will be upgraded to these versions once released.
Affected by this recall?
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Products
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
- Brand
- Accuray Incorporated
- UPC
- Product Codes: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468
Units Affected
7 units