Upper roller bracket — Class II medical device recall Z-2489-2023
Completed recall by Accuray Incorporated, reported 2023-09-06, distributed nationwide. It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearan
| Recall number | Z-2489-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2023-08-03 |
| Classified | 2023-08-31 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CO, ES, FR, GB, ID, IN, IT, JP, KR, MY, PL, SA, TH, TR, TW |
| Quantity | 82 |
| UPC / GTIN / UDI-DI | 00811376030009 |
| Serial numbers | 4010505, 4010506, 4010507, 4010508, 4010509, 4010510, 4010511, 4010513, 4010515, 4010516, 4010517, 4010518, 4010519, 4010521, 4010522, 4010523, 4010524, 4010525, 4010526, 4010527, 4010528, 4010529, 4010530, 4010531, 4010532 and 57 more |
| Model numbers | 1088370 |
Product
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Reason for recall
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
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-2489-2023. 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.