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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 61611
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-24
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Mfg Lot or Serial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lass II It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated. A second issue was discovered internally in which the Interpolation in Advantage Sim MD 7.5 would not give a correct result when some part wee removed from an existing structure. If the contour truncation is not recognized, it may lead to inappropriate irradiation of the patient. 65 Z-0754-2013
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