Device product
Xoran Minicat00202
Z-0038-2014
Product summary
- Event
- Event 66338
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320
- Official record key
device-enforcement:Z-0038-2014
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 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
Code information: minicat
Distribution pattern: Worldwide Distribution - US nationwide
Derived failure modes
-
Unknown
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