Recall Z-0039-2014— Xoran Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Xoran Technologies, Inc., initiated 2010-07-27, terminated 2014-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Xoran Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-07-27
- Terminated
- 2014-09-11
- Firm location
- Ann Arbor, MI, United States
Product description
Xoran Minicat00158
Reason for recall
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
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