TomoTherapy Treatment System — Class II medical device recall Z-2239-2014
Terminated recall by TomoTherapy Incorporated, reported 2014-08-27, distributed nationwide. Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0,
| Recall number | Z-2239-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TomoTherapy Incorporated, Madison, WI, United States |
| Recall initiated | 2014-07-17 |
| Classified | 2014-08-15 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CN, DE, ES, FR, GB, HK, IN, IT, JP, KR, MX, MY, NL, PL, RU, SA, SE, SG, SV, TH, TR, TW |
| Quantity | 322 |
| Reason classes | software |
| Serial numbers | 110003, 110005, 110006, 110009, 110014, 110016, 110020, 110022, 110023, 110024, 110026, 110030, 110034, 110035, 110036, 110039, 110040, 110041, 110042, 110044, 110045, 110046, 110047, 110048, 110049 and 295 more |
| Model numbers | H-0000-0003 |
Product
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
Reason for recall
Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). 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-2239-2014. 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.