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U.S. Department of Health and Human Services

Class 2 Device Recall AdvantageSim MD

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 Class 2 Recall
AdvantageSim MD
see related information
Date Posted August 17, 2009
Recall Status1 Open
Recall Number Z-1718-2009
Recall Event ID 51322
Premarket Notification
510(K) Number
K052345 
Product Classification System, Simulation, Radiation Therapy - Product Code KPQ
Product AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.
Code Information Serial Numbers: 00000118329GE2, 00000142883GE8, 00000142882GE0, 00000111103GE8, 00000051589GE0, 00000108666GE9, 00000127664GE1, 00000068379GE7, 00000073497GE0, 00000142884GE6, 00000051586GE6, 00000113886GE6, 00000080150GE6, 00000124934GE1, 00000073489GE7, 00000098605GE9, 00000106869GE1, 00000090499GE5, 00000090489GE6, 00000076519GE8, 00000080672GE9, 00000080481GE5, 00000134781GE4, 00000134782GE2, 00000132360GE9, 00000134789GE7, 00000069359GE8, 00000069362GE2, 00000138883GE4, 00000051665GE8, 00000051666GE6, 00000100844GE0, 00000061315GE8, 00000090495GE3, 00000076526GE3, 00000051583GE3, 00000051584GE1, 00000052631GE9, 00000109919GE1, 00000114863GE4, 00000109867GE2, 00000081296GE6, 00000108668GE5, 00000142879GE6, 00000068377GE1, 00000142878GE8, 00000138880GE0, 00000140659GE4, 00000112963GE4, 00000069347GE3, 00000134783GE0, 00000138888GE3, 00000118327GE6, 00000121720GE7, 00000109866GE4, 00000090496GE1, 00000081289GE1, 00000073483GE0, 00000106871GE7, 00000076518GE0, 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00000123786GE6, 00000080277GE7, 00000079710GE0, 00000134788GE9, 00000067041GE4, 00000112967GE5, 00000090498GE7, 00000100843GE2, 00000080276GE9, 00000096087GE2, 00000123790GE8, 00000080149GE8, 00000132367GE4, 00000142880GE4, 00000123791GE6, 00000090480GE5, 00000069350GE7, 00000079707GE6, 00000079706GE8, 00000090484GE7, 00000140655GE2, 00000124935GE8, 00000121725GE6, 00000111106GE1, 00000113883GE3, 00000108665GE1, 00000138882GE6, 00000090494GE6, 00000069363GE0, 00000051672GE2, 00000076523GE0, 00000076521GE4, 00000112964GE2, 00000082781GE6, 00000106868GE3, 00000121722GE3, 00000108672GE7, 00000068389GE6, 00000073496GE2, 00000076529GE7, 00000081297GE4, 00000081298GE2, 00000140662GE8, 00000118330GE0, 00000056499GE7, 00000109869GE8, 00000109864GE9, 00000108673GE5, 00000108674GE3, 00000109862GE3, 00000109863GE1, 00000051581GE7, 00000051582GE5, 00000051590GE8, 00000082778GE2, 00000068388GE8, 00000138884GE2, 00000068380GE5, 00000111713GE4, 00000079709GE2, 00000073495GE4, 00000098597GE8, 00000138885GE9, 00000068375GE5, 00000048215GE8, 00000085515GE5, 00000118332GE6, 00000106875GE8, 00000111104GE6, 00000138889GE1, 00000100837GE4, 00000124940GE8, 00000114867GE5, 00000118328GE4, 00000069351GE5, 00000081290GE9, 00000051587GE4, 00000140657GE8, 00000111716GE7, 00000114866GE7, 00000111105GE3, 00000068381GE3, 00000081295GE8, 00000121721GE5, 00000100841GE6, 00000144925GE5, 00000109865GE6, 00000080675GE2, 00000096084GE9, 00000082787GE3, 00000073492GE1, 00000073491GE3, 00000082785GE7, 00000069357GE2, 00000090486GE2, 00000069361GE4, 00000098582GE9, 00000068376GE3, 00000138881GE8, 00000106451GE8, 00000106450GE0, 00000111712GE6, 00000111711GE8, 00000121719GE9, 00000106870GE9, 00000145024GE6, 00000073490GE5, 00000144923GE0, 00000127666GE6, 00000073485GE5, 00000073486GE3, 00000100836GE6, 00000106872GE5, 00000114868GE3, 00000111715GE9, 00000100838GE2, 00000098604GE2, 00000069358GE0, 00000062502GE0, 00000068374GE8, 00000134785GE5, 00000112968GE3, 00000051667GE4, 00000064212GE4, 00000056504GE4, 00000098609GE1, 00000138887GE5 00000124938GE2, 00000114871GE7, 00000114870GE9, 00000127667GE4, 00000098600GE0, 00000098596GE0, 00000076531GE3, 00000098598GE6, 00000068391GE2, 00000068390GE4, 00000116935GE8, 00000051673GE2, 00000069360GE6, 00000111102GE0, 00000090488GE8, 00000090481GE3, 00000140660GE2, 00000080674GE5, 00000138886GE7, 00000012766GE3, 00000082780GE8, 00000118326GE8, 00000106448GE4, 00000108671GE9, 00000142885GE3, 00000076520GE6, 00000085513GE0, 00000127013GE1, 00000085514GE8, 00000056503GE6, 00000113881GE7, 00000109868GE0, 00000112965GE9, 00000123784GE1, 00000080483GE1, 00000140656GE0, 00000108667GE7, 00000080676GE0, 00000112962GE6, 00000068373GE0, 00000044657GE5, 00000069353GE1, 00000106873GE3, 00000067040GE6, 00000068382GE1, 00000068385GE4, 00000051669GE0, 00000068384GE7, 00000056500GE2, 00000051668GE2, 00000068383GE9, 000000D7295001, 000000B8324003, 000000L7269001, 00000054161AW5, 00000054240AW7, 00000054242AW3, 000000J7254003, 000000J8114001, 00000031588AW7, 000000Q8148002, 00000053657AW3, 00000098599GE4, 00000106876GE6, 000000C7235001, 000000X8283001, 000000X8283002, 000000S8066001, 000000U8060001, 000000N8281001, 000000P8248001, 000000T8252001, 000000N8281002, 00000031565AW5, 00000031578AW8, 00000054234AW0, 00000054239AW9, 00000054177AW1, 00000054175AW5, 00000031566AW3, 00000031577AW0, 000000Y7169004, 000000T8038001, 00000053672AW2, 000000S8343001, 000000J7254001, 00000054162AW3, 00000054244AW9, 00000054246AW4, 00000054215AW9, 00000054237AW3, 00000054192AW0, 00000054198AW7, 00000054170AW6, 00000054185AW4, 00000054184AW7, 000000G7346001, 000000Q8140006, 000000V8109004, 000000P7327002, 00000054155AW7, 000000K8295006, 000000K8021003, 00000031585AW3, 00000031572AW1, 00000031576AW2, 00000031556AW4, 00000031560AW6, 00000031580AW4, 00000031589AW5, 00000031608AW3, 00000054160AW7, 00000031579AW6, 00000054221AW7, 00000031597AW8, 00000054245AW6, 00000053662AW3, 00000054232AW4, 00000054231AW6, 00000054171AW4, 00000054191AW2, 000000Y7169001, 000000H7174001, 00000053670AW6, 00000054233AW2, 000000L7269004, 000000N7311003, 000000N7311002, 000000N8028001, 000000K8021004, 000000D7222002, 000000K8036001, 000000X8063001, 000000K8021001, 000000L7235002, 000000V8109001, 000000G8256002, 000000K8213001, 000000K7316001, 000000K8021002, 000000Q8340001, 000000B8324002, 000000C8242001, 00000054169AW8, 000000Q7351004, 00000054220AW9, 00000054200AW1, 000000L7235005, 00000054197AW9, 000000Q8140002, 000000A8049001, 000000L7235001, 00000054168AW0, 00000054164AW9, 000000Q8140004, 00000054229AW0, 00000031602AW6, 00000031604AW2, 00000031603AW4, 00000031605AW9, 00000031594AW5, 00000031601AW8, 00000031598AW6, 00000031599AW4, 00000053660AW7, 00000054151AW6, 00000053666AW4, 00000031600AW0, 00000054241AW5, 000000E7298002, 000000N7271002, 000000E7298001, 000000N7271001, 000000E7298003, 000000U8203003, 00000031557AW2, 00000031561AW4, 00000031559AW8, 00000054159AW9, 00000054188AW8, 000000L7235004, 000000J8114002, 000000V8109003, 000000J8114003, 00000054154AW0, 00000054219AW1, 000000K7316002, 00000054167AW2, 00000053650AW8, 00000031569AW7, 00000031582AW0, 00000053661AW5, 000000Q7351005, 00000053652AW4, 00000053671AW4, 000000A7178003, 000000W7360001, 000000B7310001, 00000111719GE1, 000000Y7169006, 00000112959GE2, 000000B8324001, 000000L7269002, 000000U8203002, 000000F8227001, 00000054190AW4, 00000054158AW1, 000000K8214001, 00000127011GE5, 00000031558AW0, 00000054152AW4, 00000031587AW9, 00000098606GE7, 00000098607GE5, 00000098608GE3, 00000096091GE4, 00000096090GE6, 00000054214AW2, 00000054187AW0, 000000J8135001, 000000A7178002, 000000K8295004, 00000054238AW1, 00000054172AW2, 00000054236AW5, 00000054201AW9, 00000054180AW5, 00000054228AW2, 00000054195AW3, 000000J7254005, 00000054226AW6, 00000054227AW4, 00000054222AW5, 00000054194AW6, 000000N7311001, 00000054165AW6, 00000054243AW1, 00000054210AW0, 00000054248AW0, 00000056502GE8, 00000080482GE3, 00000080148GE0, 00000080484GE9, 00000080487GE2, 00000090493GE8, 00000063728GE0, 000000S8336002, 000000S8336001, 00000031581AW2, 00000054166AW4, 00000051675GE7, 00000051676GE5, 00000054217AW5, 00000063727GE2, 00000063886GE6, 00000066231GE2, 00000069348GE1, 00000073484GE8, 00000073488GE9, 00000073493GE9, 00000073494GE7, 00000076528GE9, 00000079708GE4, 00000080478GE1, 00000080673GE7, 00000081292GE5, 00000082786GE5, 00000085512GE2, 00000090483GE9, 00000090485GE4, 00000090491GE2, 00000096088GE0, 00000098602GE6, 00000100848GE1, 00000106867GE5, 00000111710GE0, 00000114862GE6, 00000123787GE4, 00000124936GE6, 00000124942GE4, 00000124943GE2, 00000127010GE7, 00000127012GE3, 00000127663GE3, 00000127665GE8, 00000132364GE1, 00000132366GE6, 00000140658GE6, 00000144922GE2, 00000144924GE8, 00000144926GE3, 00000144929GE7, 00000144930GE5, 00000144931GE3, 00000144932GE1, 00000144933GE9, 00000144935GE4, 00000144936GE2, 00000145022GE0, 00000145023GE8, 00000145026GE1, 000000V8109002, 00000100847GE3, 000000J7254002, 000000V8023001, 000000X8063002, 00000053667AW2, 00000054179AW7, 00000054181AW3, 00000054182AW1, 00000054186AW2, 000000K8211001, 000000S7318001, 00000054178AW9, 000000G7346002, 000000N7271005, 000000P8354001, 000000Q8340002, 000000U8203001, 000000AC833301, 000000Q8148001, 00000031571AW3, 00000054189AW6, 00000054247AW2, 000000B8348001, 000000D7222001, 000000F8227002, 000000F8227003, 000000J8135002, 000000P8059001, 000000S8259001, 000000T8266001, 000000U8332003, 00000144928GE9, 00000054202AW7, 00000054205AW0, 000000H9005001, 00000054209AW2, 000000D8015001, 000000D8015002, 000000D8015003, 000000D8015004, 000000L7235003, 000000P8323001, 000000Q7351006, 000000Q8140003, 000000W7360002, 00000031562AW2, 00000031563AW0, 00000031564AW8, 00000031567AW1, 00000031568AW9, 00000031573AW9, 00000031574AW7, 00000031575AW4, 00000053664AW9, 00000054150AW8, 00000054183AW9, 000000C7253001, 000000C7253002, 000000C7324001, 000000C8234001, 000000H8235001, 000000H8298001, 000000J7254004, 000000K8217001, 000000K8220001, 000000K8295001, 000000K8295002, 000000K8295003, 000000L7269005, 000000N7271004, 000000N7313001, 000000N8301001, 000000N8350001, 000000P8059002, 000000P8059003, 000000P8059004, 000000Q7351001, 000000Q7351002, 000000Q7351003, 000000Q8140001, 000000S8207001, 000000T8309001, 000000U8060002, 000000U8203004, 000000U8332001, 000000V8023002, 000000W7360003, 000000W7360004, 000000X8063003, 000000Y7169002, 000000Y7169003, 000000ZB733801, 00000053656AW5, 00000053658AW1, 00000053659AW9, 00000053663AW1, 00000054157AW3, 00000054163AW1, 00000054206AW8, 000000B7310002, 000000B7310003, 000000L7235006, 000000L7269003, 00000053654AW0, 00000054193AW8, 00000053665AW6, 00000053668AW0, 00000053669AW8, 00000053673AW0, 00000054156AW5, 000000C8242002, 000000N8311001, 00000031595AW2, 00000031596AW0, 000000D7166001, 000000N7271003, 000000Q8148003, 000000U8332002, 000000Y7169005, 00000054199AW5, 00000054203AW5, 00000054207AW6, 00000054208AW4, 00000054225AW8, 00000121723GE1, 00000140663GE6, 00000140664GE4, 000000G8256001, 000000K8295005, 000000T8309002, 00000054196AW1, 00000080485GE6, 00000080486GE4, 00000080671GE1, 00000100835GE8 and 00000053651AW6.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare issued an "Urgent Medical Device Correction" letter dated March 11, 2009. The letter was addressed to AdvantageSim Customers, Hospital Administrators/ Risk Mangers and Oncology Department Mangers. The letter addressed the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan) and for other countries, contact your local GE Healthcare sales or field service representative.
Quantity in Commerce 687 units (351 US / 336 OUS)
Distribution Worldwide Distribution -- Including states of AL, AZ, CA, CO, CT, FL, GA, DC, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS,MO, MT,NE, NH, NJ, NM, NY, NC, ND, OH, OK PR, PA, SC, SD, TN, TX, UT, VA, WA and WI and AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TOKELAU, TURKEY, UNITED ARAB EMIRATES and the UNITED KINGDOM.
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 = KPQ and Original Applicant = GE HEALTHCARE
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