Device product
Xoran Mini CT Scanner
Z-0036-2014
Product summary
- Event
- Event 66335
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320
- Official record key
device-enforcement:Z-0036-2014
Official wording
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
Code information: Minicat
Distribution pattern: Worldwide Distribution - US nationwide
Derived failure modes
-
Unknown
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