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U.S. Department of Health and Human Services

Class 2 Device Recall Image Processing System

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 Class 2 Recall
Image Processing System
see related information
Date Posted July 09, 2012
Recall Status1 Terminated on December 06, 2012
Recall Number Z-1960-2012
Recall Event ID 61591
Premarket Notification
510(K) Numbers
K010336  K012313 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product 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).
Code Information 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
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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 th
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides safety instructions for customers to use until a software upgrade is available. Contact the firm at 800-437-1171 for questions regarding this recall.
Quantity in Commerce 70
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS, INC.
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