Accuray TomoTherapy System Recall: Dose Rotation Error Risk
Accuray recalls TomoTherapy Treatment Delivery System with iDMS due to potential dose rotation error during radiation therapy. Affected units have specific product codes and serial numbers. Contact Accuray for remedy details.
Recall notice
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Contact the company
What happened, in plain English
Accuray is recalling its TomoTherapy Treatment Delivery System with iDMS for radiation therapy. A software error may cause the delivered radiation dose to rotate from the planned dose, potentially affecting treatment accuracy. Read more at govinfonow.com/recall/63693-accuray-tomotherapy-system-recall-dose-rotation-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63693-accuray-tomotherapy-system-recall-dose-rotation-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0785-2021
Cite this page
“Accuray TomoTherapy System Recall: Dose Rotation Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63693-accuray-tomotherapy-system-recall-dose-rotation-error-risk. Based on FDA recall #Z-0785-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0785-2021%22&limit=1).
Why it’s dangerous
The 'MLC tickle error' in the system software may cause the radiation dose to rotate from the planned dose during treatment. This could lead to incorrect radiation delivery to the target tissue, potentially affecting treatment outcomes.
Who’s affected
Medical facilities using the TomoTherapy system for radiation therapy are affected. Patients receiving treatment with this system could be at risk if the dose rotation error occurs.
How to tell if you have this one
Check for product codes 104430, 1018286, H-0000-0003, 1018283 or system version 1.2 (5.6.2). Serial numbers listed include 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368.
- Brand
Accuray- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0784-2021 | 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.; Product Codes: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468 | 7 units |
| Z-0785-2021 | 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 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, | 8 units |
What to do — step by step
Check Product Details
Review the product codes and serial numbers listed in the recall notice to confirm if your system is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, New Jersey, North Dakota, Oklahoma, Utah.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0785-2021 (December 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0785-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.