TomoTherapy Treatment System — Class II medical device recall Z-2240-2014
Terminated recall by TomoTherapy Incorporated, reported 2014-08-27, distributed nationwide. Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0
| Recall number | Z-2240-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TomoTherapy Incorporated, Madison, WI, United States |
| Recall initiated | 2014-07-16 |
| Classified | 2014-08-15 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, DE, ES, FR, GB, HK, IT, JP, KR, LK, MX, NL, PH, RO, RU, TR, TW |
| Reason classes | software |
| Serial numbers | 110013, 110021, 110025, 110027, 110028, 110029, 110033, 110037, 110038, 110050, 110053, 110055, 110060, 110065, 110077, 110078, 110081, 110082, 110084, 110088, 110090, 110095, 110096, 110100, 110102 and 143 more |
| Model numbers | H-0000-0003 |
Product
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be 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 tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.
Reason for recall
Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.
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-2240-2014. 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.