FDA-Device2013-11-06Class II
Xoran Minicat00158
Xoran Technologies, Inc.
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
Sold states
Worldwide Distribution - US nationwide
Affected count
N/A
Manufactured in
5210 S State Rd, N/A, Ann Arbor, MI, United States
Products
Xoran Minicat00158
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0039-2014Don't want to check this manually?
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