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Xoran MiniCAT CT Scanner ID ENT00001

FDA Recall #Z-0041-2014 — Class II — December 14, 2009

Recall #Z-0041-2014 Date: December 14, 2009 Classification: Class II Status: Terminated

Product Description

Xoran MiniCAT CT Scanner ID ENT00001

Reason for Recall

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

Recalling Firm

Xoran Technologies, Inc. — Ann Arbor, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

320

Distribution

Worldwide Distribution - US nationwide

Code Information

minicat

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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