Cyberknife Treatment Deliver System equipped with the Xchange Robotic… — Class II medical device recall Z-2640-2026
Ongoing recall by Accuray Incorporated, reported 2026-07-08, distributed nationwide. In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from
| Recall number | Z-2640-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2026-06-16 |
| Classified | 2026-07-01 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, CO, CZ, FR, HK, JP, KR, LV, MX, SA, TR, TW, UA |
| Quantity | 48 units |
Product
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Reason for recall
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
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-2640-2026. 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.