CyberKnife Robotic Radiosurgery Systems — Class II medical device recall Z-0865-2017
Terminated recall by Accuray Incorporated, reported 2016-12-28, distributed in AZ, CA, CT, DC, FL, GA, IA, IN…. Accuray has become aware of a potential safety issue involving the possibility of electric shock during mainte
| Recall number | Z-0865-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Sunnyvale, CA, United States |
| Recall initiated | 2016-12-06 |
| Classified | 2016-12-21 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-06-09 |
| Distributed | AZ, CA, CT, DC, FL, GA, IA, IN, KS, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV |
| Countries outside the US | CN, ES, FR, GR, IT, JP, KR, MY, PK, TR, TW, VN |
| Quantity | 115 affected |
| Serial numbers | C0006, C0007, C0008, C0011, C0012, C0013, C0014, C0017, C0022, C0023, C0024, C0027, C0030, C0033, C0038, C0040, C0041, C0042, C0045, C0046, C0047, C0048, C0049, C0052, C0053 and 90 more |
Product
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. 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 the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.
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-0865-2017. 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.