510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1718-2009

AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and...

GE Healthcare / initiated 2009-02-02 / Terminated / root cause: software
FDA source (opens on fda.gov)

GE Medical Systems, LLC began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1718-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
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.
Product code
KPQ System, Simulation, Radiation Therapy
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.
Root cause tag
software
FDA root cause
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.
Product codes and lots
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, 00000068372GE2, 00000082782GE4, 00000108670GE1, 00000069349GE9, 00000123789GE0, 00000076517GE2, 00000124941GE6, 00000100849GE9, 00000063726GE4, 00000098601GE8, 00000096093GE0, 00000051671GE6, 00000090492GE0, 00000132361GE7, 00000132362GE5, 00000076522GE2, 00000098594GE5, 00000069364GE8, 00000069356GE4, 00000123785GE8, 00000076525GE5, 00000108669GE3, 00000069352GE3, 00000134784GE8, 00000096086GE4, 00000096085GE6, 00000111717GE5, 00000090490GE4, 00000076530GE5, 00000073487GE1, 00000144927GE1, 00000127009GE9, 00000081294GE1, 00000132363GE3, 00000090482GE1, 00000134787GE1, 00000121724GE9, 00000082784GE0, 00000051588GE2, 00000051679GE9, 00000064017GE7, 00000098249GE6, 00000100846GE5, 00000081291GE7, 00000121726GE4, 00000081293GE3, 00000132365GE8, 00000100842GE4, 00000080479GE9, 00000062503GE8, 00000069346GE5, 00000112961GE8, 00000112960GE0, 00000127668GE2, 00000051585GE8, 00000056501GE0, 00000121718GE1, 00000068386GE2, 00000113885GE8, 00000106449GE2, 00000106452GE6, 00000113882GE5, 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.