Accuray Incorporated Recall 86993
Description: 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.
Accuray Incorporated Recall 86993 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0785-2021 |
| Event ID | 86993 |
| Event Description | 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. |
| Product Type | Devices |
| 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. |
| Quantity | 8 units |
| Recall Reason | "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. |
| Device Classification | 20210113 |
| Device 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, |
| Center Classification Date | 20210107 |
| Recall Initiation Date | 20201210 |
| Recalling Firm | Accuray Incorporated |
| Initial Notification | Letter |
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