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Recall Observatory FDA recall evidence

Device product

Xoran MiniCAT CT Scanner ID ENT00001

Z-0041-2014

December 14, 2009

Class II

Product summary

Firm
Xoran Technologies, Inc.
Event
Event 66344
Status
Terminated
Classification
Class II
Quantity
320
Official record key
device-enforcement:Z-0041-2014

Official wording

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

Code information: minicat

Distribution pattern: Worldwide Distribution - US nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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