Class II — Accuray Incorporated
| Recalling firm | Accuray Incorporated |
|---|---|
| Registered facility | Accuray Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | 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. |
| Product | Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. |
| Quantity | 82 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, GA, IL, LA, NJ, OR, PA, SC, SD, TX, and WA. There was government distribution and no military distribution. The countries of Australia, Belgium, Canada, Colombia, France, India, Indonesia, Italy, Japan, Kazakhstan, Malaysia, Poland, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom. |
| Initiated | 2023-08-03 |
| Classified | 2023-08-31 |
| Recall number | Z-2489-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Accuray Incorporated (Z-2489-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92772/
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