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U.S. Department of Health and Human Services

Class 2 Device Recall Seno Advantage medical image review station

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 Class 2 Recall
Seno Advantage medical image review station
see related information
Date Posted September 19, 2013
Recall Status1 Open
Recall Number Z-2257-2013
Recall Event ID 66126
Premarket Notification
510(K) Number
K033400 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. 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.
Code Information Seno Advantage Workstations with RIS CCOW integration: Patient mismatch while receiving images - FMI 12187 Serial # 00000179275GE3 00000136608GE7 00000136609GE5 00000123803GE9 00000206492GE1 00000179274GE6 00000179273GE8 00000179272GE0 00000177331GE6 00000128528GE7 00000132314GE6 00000106422GE9 00000188371GE9 00000179281GE1 00000179282GE9 00000106426GE0 00000106427GE8 00000250274GE8 00000142837GE4 00000142836GE6 000000010001GS 00000114907GE9 00000158810GE2 00000084251GE8 00000112122GE7 00000123807GE0 000000310001GS 000000010008GS 000000010007GS 00000106420GE3 00000114906GE1 00000250277GE1 00000165231GE2 00000136610GE3 00000114088GE8 00000114089GE6 00000112926GE1 00000206490GE5 00000154938GE5 00000190211HP3 00000174027GE3 00000174026GE5 00000190278HP2 000000010004GS 00000164500GE1 00000158809GE4 00000158410GE1 00000165228GE8 00000165229GE6 00000123804GE7 00000166277GE4 00000114091GE2 00000106425GE2 00000106424GE5 00000179280GE3 00000200442GE2 00000250278GE9 00000126082GE7 00000206491GE3 00000164502GE7 00000164503GE5 000000510001GS 00000253622GE5 00000128529GE5 00000126080GE1 00000195402GE3 00000195403GE1 00000218675GE7 00000218674GE0 00000220618GE3 000000010011GS 00000190212HP1 00000220619GE1 000003510001GS 00000117141GE2 00000142832GE5 00000200440GE6 000003310002GS 00000022062GE9 000003310001GS 00000250290GE4 00000295750GE4 00000295751GE2 00000250276GE3 00000295753GE8 00000295752GE0 00000158812GE8 00000166279GE0 000000610001GS 00000075247GE7 00000106423GE7 00000080399GE9 000000610005GS 00000170113GE2 00000L02687311 000000ANT26269 000000G8087001 000000ANT23044 000000ANT25613 000000C7177002 00000193277GE1 00000149802GE1 00000149801GE3 00000165230GE4 000003510003GS 000000310002GS 000000310003GS 000004410002GS 000000610002GS 00000126078GE5 00000126079GE3 000000210002GS 00000164501GE9 00000117137GE0 00000119932GE2 00000142838GE2 000000Q7274004 000000M9335002 000000Q7274002 000000010005GS 000000N7302006 000000C7177009 000000C7177015 00000050606AW3 000000K7291002 000000Q7274005 000000C7177008 000000C7177010 00000Q11031001 00000Q11031003 000000610006GS 0000AG12200001 000000G9278001 00000L11224002 00000H11230001 0000ZA11210001 00000F11278001 0000AT11264001 000000S8340001 000000010001GS 00000J10019001 00000ZA9233001 00000N10193003 00000D10166001 000000B7339013 00000H11230002 0000AL11360001 00000H12052001 00000J11314001 000000S8135001 000000010003GS 000000T9021003 000000C7177020 000000010002GS 000000U7164006 00000050607AW1 000000Q7274001 00000054750AW5 00000054849AW5 000000010006GS 000000W9301001 000000T7250001 000000T7323003 000000T7323002 000000P8081001 000000S8135002 000000G8021002 00000050605AW5 00000050604AW8 00000G10264001 00000N10071001 00000P10046001 000000C7177019 0000AB11012002 00000M11006003 0000AB11012001 00000R11320001 000000R9058001 0000AT11264003
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 recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.
FDA Determined
Cause 2
DESIGN: Software Design Change
Action GE Healthcare sent an Important Product Information letter dated September 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety. The Contact Information (US 800-437-1171, Japan 0120-055-919, Other countries contact local GE Healthcare Service Representative).
Quantity in Commerce 179
Distribution Worldwide Distribution - USA (nationwide) including the states of : AL AZ, CA, CO, CT, FL, GA, IL, IN, MD,MI, MO, NJ, NY, NC, OK, PA, TX and WI., and the countries of : AUSTRIA, BELGIUM, CANADA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, JAPAN, LEBANON, NORWAY, PORTUGAL, SPAIN, SWEDEN and TAIWAN.
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 W-400
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