Device product

Xoran MiniCAT00202

Z-0040-2014

July 27, 2010

Class II

Product summary

Firm: Xoran Technologies, Inc.
Event: Event 66340
Status: Terminated
Classification: Class II
Quantity: 320
Official record key: device-enforcement:Z-0040-2014

Official wording

Reason: 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 Xorans specifications.

Code information: minicat

Distribution pattern: Worldwide Distribution - Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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 Xorans specifications.