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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 Initiated by Firm September 20, 2012
Date Posted September 19, 2013
Recall Status1 Completed
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
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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