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U.S. Department of Health and Human Services

Class 2 Device Recall Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1

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 Class 2 Recall
Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1
see related information
Date Posted October 19, 2012
Recall Status1 Terminated on March 26, 2013
Recall Number Z-0095-2013
Recall Event ID 61603
Premarket Notification
510(K) Number
K033400 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: 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 Mfg Lot or Serial # SA2 000000410032GS 000000410033GS 000000410027GS 000000410047GS 000000410041GS 000000410051GS 000000410087GS 000000410065GS 000000410031GS 000000410035GS 000000410136GS 000000410064GS 000000410037GS 000000410030GS 000000410049GS 000000410028GS 000000410113GS 000000410069GS 000000410052GS 000000410056GS 000000410043GS 000000410044GS 000000410048GS 000000410038GS 000000410042GS 000000410101GS 000000410036GS 000000410039GS 000000410073GS 000000410054GS 000000410134GS 000000410062GS 000000410112GS 000000410045GS 000000410063GS 000000410060GS 000000410034GS 000000410072GS 000000410057GS 000000410061GS 000000410058GS 000000410050GS 000000410071GS 000000410059GS 000000410055GS 000000410070GS 000000410053GS 000000410029GS 000000410067GS 000000410068GS 000000410066GS 000000410133GS 000000410011GS 000000410010GS 000000410009GS 000000410007GS 000000410006GS 000000410008GS 000000410096GS 000000410089GS 000000410090GS 000000410088GS 000000410086GS 000000410001GS 000000410046GS 000000410040GS 000000410014GS 000000410013GS 000000410015GS 000000410012GS 000000410022GS 00000L0265F2Fe 000000410016GS 000000410018GS 00000L02746AAA 000000410005GS 000000410019GS 000000410017GS 000000410023GS 000000410024GS 00000L0215A2F7 000000410020GS 000000410021GS 000000410109GS 000000410104GS 000000410103GS 000000410105GS 000000410106GS 000000410107GS 000000410102GS 000000410119GS 000000410108GS 000000410091GS 000000410098GS 000000410100GS 000000410082GS 000000410135GS 000000410078GS 000000410079GS 000000410085GS 000000410081GS 000000410080GS 000000410093GS 000000410094GS 000000410083GS 000000410084GS 000000410077GS 000000410076GS 000000410075GS 00000L028421B6 000000410124GS 000000410127GS 000000410120GS 000000410125GS 000000410131GS 000000410132GS 000000410123GS 000000410122GS 000000410126GS 000000410121GS 000000410128GS 000000410130GS 000000410129GS 000000410025GS 00000L021564F6 000000410092GS 000000410074GS 000000410117GS 000000410099GS 000000410114GS 000000410026GS 000000410111GS 00000L02A95ABE 000000410115GS 000000410116GS 000000410118GS 000000410002GS 000000410110GS 000000410097GS 000000410095GS 000000410138GS 000000410004GS 000000410003GS 000000410137GS FMI# 12129_SA1.x Mfg Lot or Serial # 00000L0238B0F6 00000L02AB16F5 00000L02227D84 00000L0221EDA2 00000LEE1BC987 00000LEE1F8870 00000L0235C516 00000L020136EE 00000L02510750 00000L027207CA 00000L02700093 00000LEE1F8744 00000L02227BAC 00000L02373AF4 00000LEE1F849C 00000L0265F748 00000LEE1F83BF 00000L0236BA7C 00000L023825D4 00000L025FB4AA 00000L0238B098 00000L025B5665 00000L025B53AF 00000L0265F50E 00000L0265FAC2 00000L0265F6AB 00000LEE1F85D1 00000L025B539D 00000L0235B91A 00000LEE1F8616 00000L0265F995 00000L025D689A 00000L0235C7DA 00000LEE1F8747 00000L0265F547 00000L0235B8DA 00000L02227CC2 00000L0235C642 00000LEE1F8896 00000L02227DF4 00000L023A0BBE 00000L025B53A8 00000L025B53A5 00000L02068226
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent a Urgent Medical Device Correction letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will install new software to correct this issue with the release of Field Modification Instruction (FMI) 12129 in the near future. This correction will not affect the performance or any other functionality of your current equipment. A GE Healthcare service representative will contact you to arrange for this modification. This activity will be performed at no cost to you. 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 188
Distribution Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, DC, FL, GA, KY,LA, MA, MO, NV, NJ, NY, NC, OH, OK, PA, SD, TN, TX, VA and WI., and the countries of UNITED KINGDOM, TUKEY, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL, NEW ZEALAND, NETHERLANDS, MEXICO, MALAYSIA, KOREA, JAPAN, ITALY, HUNGARY, GREECE, GERMANY, FRANCE, CHINA, CANADA, BRAZIL, AUSTRIA and ALGERIA.
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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