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.
FDA Recall Z-0784-2021 · Posted None
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Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2020-12-10
Date Terminated2022-09-26
Product Quantity7 units
Reason for Recall
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Firm Action
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.
Root Cause
Software Design Change
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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