Recall Z-0036-2014 ยท JAK System, X-Ray, Tomography, Computed
Xoran Technologies, Inc.
Xoran Mini CT Scanner
| Date | Jul 27, 2010 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Radiation Control for Health and Safety Act |
| Action | All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component. |
| Quantity | 320 |
| Distribution | Worldwide Distribution - US nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.