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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 66340
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 2010-07-27
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Xoran MiniCAT00202 minicat Class II 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. 320 Z-0040-2014
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