Recall Z-0785-2021
Accuray Incorporated · initiated December 10, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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,
Reason for recall
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
FDA-determined 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.
Details
- Recall number
- Z-0785-2021
- Initiated
- December 10, 2020
- Terminated
- September 26, 2022
- Product code
- IYE – Accelerator, Linear, Medical
- Quantity
- 8 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.
- Recalling firm
- Accuray Incorporated, Madison, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0784-2021 Class II | TomoTherapy Treatment System - Product Usage: used as an integrated system for the…"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. | 12/10/2020Terminated |