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.
This recall has been terminated (originally issued December 10, 2020).
- Company
- Accuray Incorporated
- Recall Initiated
- December 10, 2020
- Terminated
- September 26, 2022
- Recall Number
- Z-0785-2021
- Quantity
- 8 units
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for Recall
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
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.
Lot / Code Info
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,
Root Cause
Software Design Change
Action Taken
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.