Xoran Minicat00158
This recall has been terminated (originally issued July 27, 2010).
- Company
- Xoran Technologies, Inc.
- Recall Initiated
- July 27, 2010
- Terminated
- September 11, 2014
- Recall Number
- Z-0039-2014
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
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 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
Distribution
Worldwide Distribution - US nationwide
Lot / Code Info
minicat
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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 to evaluating the stability of the dose rating.