FDA Device recall Z-0784-2021
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, ster…
- FDA Device
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, ster… by Accuray, citing "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0784-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-10 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Accuray |
| Distribution | US |
Product
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.
Reason
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Identifiers
| code_info | Product Codes: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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FDA Device · Class II · 2026-07-08 · Accuray - Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
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FDA Device · Class II · 2025-02-05 · Accuray - Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
FDA Device · Class II · 2023-09-06 · Accuray - CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for l…
FDA Device · Class II · 2021-03-24 · Accuray
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0784-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.