Xoran Mini CT Scanner — Class II medical device recall Z-0036-2014
Terminated recall by Xoran Technologies, Inc., reported 2013-11-06, distributed nationwide. A description of the defect in the product or the manner in which the product fails to comply with an applicab
| Recall number | Z-0036-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xoran Technologies, Inc., Ann Arbor, MI, United States |
| Recall initiated | 2010-07-27 |
| Classified | 2013-10-25 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 320 |
Product
Xoran Mini CT Scanner
Reason for recall
A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; 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 evalu
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-0036-2014. 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.