CyberKnife M6 — Class II medical device recall Z-0408-2019
Terminated recall by Accuray Incorporated, reported 2018-11-14. A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and
| Recall number | Z-0408-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2018-09-26 |
| Classified | 2018-11-08 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2021-05-12 |
| Quantity | 93 units |
| Serial numbers | C0330, C0332, C0334, C0335, C0336, C0337, C0338, C0342, C0343, C0344, C0345, C0346, C0348, C0349, C0351, C0352, C0354, C0356, C0358, C0359, C0360, C0361, C0363, C0364, C0366 and 68 more |
| Model numbers | 054000-004 |
Product
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are 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
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
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-0408-2019. 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.