Recall Z-0037-2014 ยท JAK System, X-Ray, Tomography, Computed
Xoran Technologies, Inc.
Xoran MiniCAT 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 wvith 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. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard |
| Quantity | 320 |
| Distribution | Worldwide Distribution - Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.