TomoTherapy Treatment Delivery System with iDMS — Class II medical device recall Z-0785-2021
Terminated recall by Accuray Incorporated, reported 2021-01-13, distributed nationwide. "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
| Recall number | Z-0785-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2020-12-10 |
| Classified | 2021-01-07 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2022-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CH, CN, IT |
| Quantity | 8 units |
| Serial numbers | 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368 |
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.
Reason for recall
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0785-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.