Xoran MiniCAT X-ray imaging device — Class II medical device recall Z-1210-2015
Terminated recall by Xoran Technologies, LLC, reported 2015-03-11, distributed nationwide. Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
| Recall number | Z-1210-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xoran Technologies, LLC, Ann Arbor, MI, United States |
| Recall initiated | 2014-09-08 |
| Classified | 2015-03-02 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2016-02-02 |
| Distributed | Nationwide (US) |
| Quantity | 432 |
Product
Xoran MiniCAT X-ray imaging device
Reason for recall
Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
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-1210-2015. 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.