Known Identifiers & Locations
FEI Numbers
3004198450
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (6)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0036-2014 |
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
|
2010-07-27 |
Terminated
|
View Details
|
| Z-0037-2014 |
Xoran MiniCAT CT Scanner
Reason: A description of the defect in the product or the manner in which the product fails to comply wvith 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
|
2010-07-27 |
Terminated
|
View Details
|
| Z-0038-2014 |
Xoran Minicat00202
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
|
2010-07-27 |
Terminated
|
View Details
|
| Z-0039-2014 |
Xoran Minicat00158
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
|
2010-07-27 |
Terminated
|
View Details
|
| Z-0040-2014 |
Xoran MiniCAT00202
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.
|
2010-07-27 |
Terminated
|
View Details
|
| Z-0041-2014 |
Xoran MiniCAT CT Scanner ID ENT00001
Reason: Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
|
2009-12-14 |
Terminated
|
View Details
|
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