CyberKnife M6 — Class II medical device recall Z-1696-2019
Terminated recall by Accuray Incorporated, reported 2019-06-12. There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workfl
| Recall number | Z-1696-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2018-04-10 |
| Classified | 2019-05-31 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2021-04-01 |
| Countries outside the US | AE, AU, BE, CA, CH, DE, FR, GB, HU, IN, IT, JP, LU, LV, NL, PL, PT, QA, TH, TR |
| Quantity | 68 units |
| Serial numbers | C0330, C0332, C0334, C0337, C0342, C0343, C0344, C0345, C0348, C0349, C0352, C0358, C0359, C0360, C0363, C0364, C0367, C0370, C0371, C0372, C0378, C0381, C0384, C0387, C0389 and 43 more |
Product
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
Reason for recall
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
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-1696-2019. 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.