FDA-Device2013-11-06Class II
Xoran MiniCAT00202
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 Xorans specifications.
Sold states
Worldwide Distribution - Nationwide
Affected count
320
Manufactured in
5210 S State Rd, N/A, Ann Arbor, MI, United States
Products
Xoran MiniCAT00202
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0040-2014Don't want to check this manually?
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