CyberKnife Robotic Radiosurgery System using software version 10 — Class II medical device recall Z-0734-2017
Terminated recall by Accuray Incorporated, reported 2016-12-21, distributed in AK, CA, FL, KY, MN, MT, NJ, NY…. Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing
| Recall number | Z-0734-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Sunnyvale, CA, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2016-12-12 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2017-05-22 |
| Distributed | AK, CA, FL, KY, MN, MT, NJ, NY, PA, SC, WA, WI |
| Countries outside the US | BG, CA, CH, DE, FR, IN, JP, LU, NL, PT, TR |
| Quantity | 40 affected |
| Reason classes | software |
| Serial numbers | C0330, C0334, C0336, C0338, C0342, C0344, C0348, C0349, C0351, C0358, C0359, C0360, C0361, C0363, C0364, C0366, C0367, C0370, C0372, C0376, C0387, C0389, C0390, C0391, C0393 and 15 more |
| Model numbers | 54000 |
Product
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife¿ Systems with software version 1 0.6.
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-0734-2017. 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.