Xoran MiniCAT00202 — Class II medical device recall Z-0040-2014
Terminated recall by Xoran Technologies, Inc., reported 2013-11-06, distributed nationwide. The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 12
| Recall number | Z-0040-2014 |
|---|---|
| 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 MiniCAT00202
Reason for recall
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 Xorans specifications.
Machine access
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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.