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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66344
Product Type Devices
Status Ongoing
Recalling Firm Xoran Technologies, Inc.
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-12-14
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - US nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Xoran MiniCAT CT Scanner ID ENT00001 minicat Class II Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate. 320 Z-0041-2014