TomoTherapy Treatment System with software versions 2 — Class II medical device recall Z-0507-2015
Terminated recall by TomoTherapy Incorporated, reported 2014-12-17, distributed nationwide. Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a f
| Recall number | Z-0507-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TomoTherapy Incorporated, Madison, WI, United States |
| Recall initiated | 2014-11-21 |
| Classified | 2014-12-05 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, DE, ES, FR, GB, GR, HK, IT, JP, KR, LK, MX, NL, PH, RO, TR |
Product
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Reason for recall
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.
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-0507-2015. 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.