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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 66335
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 - US nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Xoran Mini CT Scanner Minicat Class II A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; 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 Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. 320 Z-0036-2014
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