Recall Z-0784-2021 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
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.
| Date | Dec 10, 2020 |
| Status | Terminated |
| Reason | "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. |
| Root cause | Software Design Change |
| 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. |
| Quantity | 7 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121934 | TOMOTHERAPY TREATMENT SYSTEM Accuray Incorporated, Aug 29, 2012 |