CyberKnife Robotic — Class II medical device recall Z-0771-2016
Terminated recall by Accuray Incorporated, reported 2016-02-17, distributed nationwide. The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) positio
| Recall number | Z-0771-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Sunnyvale, CA, United States |
| Recall initiated | 2016-01-22 |
| Classified | 2016-02-08 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-10-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, CN, CO, CZ, DE, ES, FI, FR, GB, GR, IE, IN, IT, JP, KR, MX, PK, PL, RU, SA, TH, TR, TW, UA, VE |
| Quantity | 226 |
| Reason classes | device malfunction |
| Model numbers | 032000, 033000 |
Product
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: 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
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
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-0771-2016. 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.