FDA Recall
Terminated
Xoran Mini CT Scanner
Recall: Z-0036-2014
·
Initiated July 27, 2010
Recall
- Recall Number
- Z-0036-2014
- Event Number
- 66335
- Firm
- Xoran Technologies, Inc.
- FEI Number
- 3004198450
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- July 27, 2010
- Terminated
- September 11, 2014
- Address
- 5210 S State Rd, Ann Arbor, MI, 48108-7936
Description
Xoran Mini CT Scanner
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
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.
Distribution
Worldwide Distribution - US nationwide
Quantity
320