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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, AW Server.

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 Class 2 Recall
GE Healthcare, AW Server.
see related information
Date Posted April 17, 2013
Recall Status1 Terminated on February 04, 2014
Recall Number Z-1137-2013
Recall Event ID 64900
Premarket Notification
510(K) Number
K081985 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent an "Important Product Information" letter dated June 27, 2012. The letter was addressed to Hospital Administrators , Radiology Managers and Risk Managers. The letter described the Subject, Instructions and Affected Product Details. GE Healthcare will correct all affected product by providing a software upgrade at no cost. For questions call: US 800-437-1171, Japan 0120-055-919, and/or local GE Healthcare Service Representative.
Quantity in Commerce 429
Distribution Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES.
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, LLC
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