Drug recall
Xoran MiniCAT00202
FDA recall event 66340 · Class II · Xoran Technologies, Inc.
Key facts
| Event ID | 66340 |
|---|---|
| Recall numbers | Z-0040-2014 |
| Recalling firm | Xoran Technologies, Inc. |
| Product type | Devices |
| Products | Xoran MiniCAT00202 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 27, 2010 |
| Report date | Nov 6, 2013 |
| Termination date | Sep 11, 2014 |
| City | Ann Arbor |
| State | MI |
| Country | United States |
| FEI number | 3004198450 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: