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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 66338
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 Minicat00158 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 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. A copy of the health hazard evaluation may be found in ATTACHMENT 2. Z-0039-2014
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 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. A copy of the health hazard evaluation may be found in ATTACHMENT 2. 320 Z-0038-2014
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