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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 Device Recall Seno Advantage medical image review station see related information
Date Posted September 19, 2013
Recall Status1 Terminated
Recall Number Z-2257-2013
Recall Event ID 66126
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 WI 53188-1615
For Additional Information Contact
262-513-4122
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
Software design
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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