Class II — Xoran Technologies, Inc.
| Recalling firm | Xoran Technologies LLC |
|---|---|
| Registered facility | Xoran Technologies, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha |
| Product | Xoran Minicat00158 |
| Quantity | N/A |
| Distribution | Worldwide Distribution - US nationwide |
| Initiated | 2010-07-27 |
| Classified | 2013-10-25 |
| Terminated | 2014-09-11 |
| Recall number | Z-0039-2014 |
| 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 — Xoran Technologies, Inc. (Z-0039-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66338/
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