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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare AW Server

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 Class 2 Recall
GE Healthcare AW Server
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on July 03, 2012
Recall Number Z-0486-2012
Recall Event ID 60357
Premarket Notification
510(K) Number
K081985 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare AW Server version 2.0 with release 2.0 - 4.0 A medical software system that allows multiple users to remotely access AW applications from compatible computers on a network.
Code Information Serial Number 00000196120GE0 00000211977GE4 00000211976GE6 00000211975GE8 00000213559GE8 00000213558GE0 00000209172GE6 00000211978GE2 00000214205GE7 00000214206GE5 00000214821GE1 00000216331GE9 00000217429GE0 00000217427GE4 00000217428GE2 00000217426GE6 00000218090GE9 00000216334GE3 00000214817GE9 00000219372GE0 00000218207GE9 00000214818GE7 00000218205GE3 00000216335GE0 00000222534GE0 00000219371GE2 00000222536GE5 00000222533GE2 00000223236GE1 00000223240GE3 00000223235GE3 00000223242GE9 00000223234GE6 00000223243GE7 00000222535GE7 00000216337GE6 00000223238GE7 00000216340GE0 00000216336GE8 00000216338GE4 00000183554HP5 00000183573HP5 00000183555HP2 00000183518HP0 00000183570HP1 00000183568HP5 00000183562HP8 00000183557HP8 00000183561HP0 00000183558HP6 00000183567HP7 00000183563HP6 00000183565HP1 000001010056GS 000001010012GS 00000229342GE1 00000229343GE9 00000229341GE3 00000229339GE7 00000235883GE6 00000235884GE4 00000235885GE1 00000235886GE9 00000240703GE9 00000240704GE7 00000240705GE4 00000240706GE2 00000240707GE0 00000240708GE8 00000246497GE2 00000246498GE0 00000248243GE8 00000248244GE6 00000246500GE3 00000253048GE3 000001010023GS 0000AD11104005 0000AD11104004 00000P10347010 00000Y11013009 0000AB11054003 00000A11096009 00000P10347005 0000AD11087005 000001010019GS 000001010045GS 00000P11244008 00000Z10335002 00000Y11013001 000001010024GS 000001010040GS 00000F11206003 00000V11136003 00000P10312010 000001010041GS 00000A11096003 0000AA11157004 00000L11074006 00000P10312008 00000P10347003 00000V11185002 00000L11074004 00000J11056005 00000P10347007 0000AB11054004 0000AB11054002 0000AB11054005 00000L11074009 00000L11074002 00000L11074007 00000L11074003 0000AD11087001 0000AD11104003 0000AD11104002 0000AD11104001 00000A11096004 000001010004GS 000001010003GS 000001010005GS 00000A11096002 00000L11071009 0000AD11138002 0000AD11087003 00000183531HP3 000001010042GS 000001010044GS 000001010043GS 00000A11096006 0000AB10329002 00000Z10335010 00000Z10335006 000001010016GS 000001010018GS 000001010022GS 000001010017GS 000001010057GS 00000K11199001 00000C11263003 00000183514HP9 000001010059GS 00000P11244012 00000K11152002 00000P10312002 00000E11026009 00000E11026008 00000E11026002 00000Y11013003 00000P10347009 00000P10347011 00000J11056002 00000J11056001 00000J11056003 00000J11056004 000001010001GS 000001010002GS 000001010027GS 00000V11136005 00000F11206002 00000P11244013 00000P10312001 0000AB10329001 0000AB10329003 00000Z10335003 00000Z10335004 00000Z10335008 00000Y11013008 00000Y11013007 00000E11026005 000001010026GS 000001010013GS 0000AD11138005 0000AD11138003 00000K11230001 00000P11244001 00000P10312007 00000P10312005 00000Z10335005 00000Z10335007 00000Z10335001 00000P10347004 00000P10312003 00000G10363002 00000P10347008 00000G10363001 00000Y11013002 00000Y11013010 00000Y11013005 00000E11026007 00000E11026010 00000E11026003 00000P10312009 00000E11026001 00000E11026004 00000L11074005 0000AD11087004 00000183537HP0 00000183552HP9 00000183528HP9 00000183506HP5 00000183527HP1 00000183540HP4 00000183579HP2 00000183497HP7 00000183578HP4 00000183532HP1 00000183543HP8 00000A11096005 00000183510HP7 00000183530HP5 000001010032GS 000001010031GS 000001010050GS 000001010030GS 000001010033GS 000001010028GS 000001010020GS 000001010015GS 000001010048GS 000001010037GS 000001010038GS 000001010047GS 000001010021GS 000001010039GS 000001010049GS 000001010035GS 000001010046GS 000001010051GS 000001010036GS 000001010055GS 000001010054GS 00000A11096001 00000A11096007 00000183501HP6 00000V11136001 00000V11136006 00000V11136002 00000V11136007 00000V11136009 00000V11136008 00000K11152008 0000AA11157001 0000AA11157010 0000AA11157007 0000AA11157002 00000183502HP4 00000183539HP6 0000AA11157006 00000K11152005 00000183581HP8 00000183577HP6 00000K11152001 00000V11185003 00000K11152006 00000F11206005 0000AA11157005 00000F11206006 00000F11206001 00000V11185005 00000F11236001 00000K11152007 00000P11244009 00000K11152004 00000P11244010 00000P11244006 00000P11244004 00000P11244003 00000P11244007 00000F11250001 00000K11152003 00000C11263004 00000C11263001 0000ZA10286001 0000AA11157003 000001010025GS 0000AD11087002 00000P10312004 00000P10347001 0000AD11138001 00000216333GE5 00000217425GE8 00000214819GE5 00000217424GE1 00000218091GE7 00000218206GE1 00000216332GE7 00000223239GE5 00000183574HP3 00000183523HP0 00000229344GE7 00000235882GE8 00000246496GE4 00000248248GE7 00000248245GE3 00000248247GE9 00000183571HP9 000001010061GS 00000L11074001 00000Z10335009 00000P10347006 00000P10347012 000001010007GS 000001010009GS 000001010008GS 000001010052GS 00000E11026006 0000AB11054001 0000AA11157008 00000F11206004
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also, if a second patient exam is selected while the application is starting, the second patient's data will be displayed with the first patient's name display on the applications tab.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent on 11/17/11 a GE "Urgent Medical Device Correction" letters dated November, 16 2011 The letter was addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letter described the Safety Issue, Safety Instructions Affected Product Details, Product Correction and Contact Information. For the first issue, customers were asked to contact their field engineer to install the correct configuration file. Also, customers should not apply the recommended changes from the Customer Release Note as those changes cause the issue to occur. With the second issue, customers are to wait until the application has fully initialized before making another patient exam selection. GE Healthcare will correct all affected AW server installations via a software upgrade at no cost to the customer. A representative will contact customers to arrange for the correction. Questions should be directed to customers' local GE Healthcare Service Representative or at the numbers provided in the letter.
Quantity in Commerce 308
Distribution Worldwide Distribution -- USA, including states of AZ, CA, CO, CT, DE, DC, FL, HI, IL, IN, LA, MD, MI, MN, MS,MO, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, and WI and countries of UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, REUNION, QATAR, POLAND, NORWAY, NEW ZEALAND, LEBANON, SOUTH KOREA, JAPAN, ITALY, ISRAEL, HONG KONG, GUADELOUPE, GREAT BRITAIN, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CANADA, BRAZIL, BOSNIA AND HERZEGOVINA, BELGIUM, and AUSTRALIA.
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, LLC
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