TomoHDA — Class II medical device recall Z-0289-2018
Terminated recall by Accuray Incorporated, reported 2018-01-03. Uncontrolled couch Z-axis movement (descent)
| Recall number | Z-0289-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2017-11-17 |
| Classified | 2017-12-26 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2021-07-25 |
| Quantity | 87 units |
| Serial numbers | 110033, 110137, 110155, 110206, 110221, 110290, 110318, 110348, 110353, 110360, 110364, 110384, 110408, 110410, 110411, 110452, 110457, 110463, 110473, 110475, 110476, 110477, 110478, 110479, 110481 and 62 more |
| Model numbers | 1018286 |
Product
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he 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/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
Reason for recall
Uncontrolled couch Z-axis movement (descent)
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-0289-2018. 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.