FDA-Device2013-11-06Class II

Xoran MiniCAT CT Scanner ID ENT00001

Xoran Technologies, Inc.
Hazard

Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

Sold states
Worldwide Distribution - US nationwide
Affected count
320
Manufactured in
5210 S State Rd, N/A, Ann Arbor, MI, United States
Products
Xoran MiniCAT CT Scanner ID ENT00001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0041-2014

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