FDA Device recall Z-0038-2014
Xoran Minicat00202
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Xoran Minicat00202 by Xoran Technologies, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0038-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-07-27 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Xoran Technologies |
| Distribution | US |
Product
Xoran Minicat00202
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
Identifiers
| code_info | minicat |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0038-2014%22
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