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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations

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 Class 2 Recall
GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations
see related information
Date Posted August 12, 2011
Recall Status1 Terminated on June 29, 2012
Recall Number Z-3012-2011
Recall Event ID 59059
Premarket Notification
510(K) Numbers
K033400  K052995 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
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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 that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety. When Seno Advantage workstation is synchronized with RIS using CCOW (an HL7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1. Two different
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent a URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated May 31, 2011. The letter identified the product , the problem and the action needed to be taken by the customer. GE Healthcare will upgrade all affected workstations at no cost. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative.
Quantity in Commerce 391
Distribution Worldwide Distribution--USA (nationwide) including the states of: AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OK, OR, PA, SC, TN,TX, and WI, and the countries of UNITED KINGDOM, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, PORTUGAL NORWAY, NEW ZEALAND, LUXEMBOURG, LEBANON, KOREA, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, DENMARK, CANADA, BELGIUM AUSTRIA, AUSTRALIA FINLAND.
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 HEALTHCARE
510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS W-400
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