Accuray CyberKnife Robotic Radiosurgery System — Class II medical device recall Z-0828-2014
Terminated recall by Accuray Incorporated, reported 2014-02-05, distributed nationwide. Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detachin
| Recall number | Z-0828-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Sunnyvale, CA, United States |
| Recall initiated | 2014-01-13 |
| Classified | 2014-01-27 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2014-11-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, CO, CZ, DE, ES, FI, FR, GB, GR, IE, IN, IT, JP, KR, LU, MX, MY, NL, PL, RU, TH, TR, TW, UA, VE, VN |
| Reason classes | device malfunction |
| Serial numbers | C0006, C0007, C0008, C0012, C0013, C0014, C0019, C0020, C0022, C0030, C0032, C0033, C0037, C0038, C0041, C0042, C0045, C0046, C0047, C0048, C0049, C0051, C0052, C0053, C0054 and 276 more |
| Model numbers | 054000-001 |
Product
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Reason for recall
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
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-0828-2014. 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.