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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description Xoran MiniCAT00202
Recall Number Z-0040-2014
Classification Class II
Code Info minicat
Product Distributed Qty 320
Reason For Recall 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.

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