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Xoran Technologies, Inc. recalls Xoran Minicat00158
Recalled November 6, 2013 · FDA recall Z-0039-2014 · Xoran Technologies
Hazard
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 · FDA Class II
Units
N/A
Sold at
Worldwide Distribution - US nationwide
Description
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
Product
Xoran Minicat00158
Manufacturer(s)
Xoran Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →