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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 61591
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 (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and the countries of TURKEY, TUNISIA, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, KENYA, JAPAN, ITALY, IRELAND, INDIA, GREAT BRITAIN, GERMANY, FRANCE, EGYPT, CHILE, CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, and ARGENTINA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET). 261AWUSV35007H7 10026AW 514934BAR14 26329AW2 ACBCTAW7 956632AW42 321799AW1 617355AWPC1 617355AW3 361595SKW1 617754MR5AW 3454AWW 3526 941747AWW 212639XL5 239436AW2 773792AW1 803366AW1 813642AW42 973972AWW3 973972AWW5 210292AW41C 082445030001AW 082445010004AW 082421010160AW 082421120176AW 082406200003AW 082421150050AW 082416130012AW 082445150008AW 082421100265AW 082421050047AW 083049822101584 083055602101433 083055065231713 083049842101695 PT0004 PT0023 0847490042 0853550153 0853550221 AH4511AW01 030070OT02 EG1277AW01 M4017059 PC0125AW02 PC0815AW03 PC0362AW04 IE1005AW02 A5248812 A5158021 A5226504 KE1000AW01 RU2441AW02 SA1054AW01 NP083626 MP825712 FPG72503 0853550150 TN1003AW02 06056DCS01 70001ADW06 00327ADW01 58831121222 L0235B396 321mraw 420686AW01 B4192933 CC0618AW04 M27534 Class II GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to the same precision as the scanner. Assuming the two images are acquired with a calibrated machine and there is no patient movement between the CT and PET acquisitions, the two images should be visually aligned to a precision of less than one half PET voxel. However, the problem associated with this version of software may introduce a shift of up to 1.5 PET voxels, which can be as much as 8mm with certain zoom factors. 70 Z-1960-2012
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