Devices

Device Recall AdvantageSim MD

  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall AdvantageSim MD
  • Model / Serial
    Mfg Lot or Serial # 00000L022E05AE 00000139595HP3 000000010003GS 000000410012GS 000000210016GS 000000210013GS 00000138998HP0 00000139435HP2 000000410010GS 000000410009GS 000000210005GS 000000210011GS 000000210012GS 000000210015GS 00000138991HP5 000000210014GS 000000310005GS 00000139574HP8 00000139604HP3 00000L026CC222 000000210010GS 000000010004GS 000000410011GS 000000410007GS 000000210023GS 000000210025GS 000000210026GS 000000210022GS 000000210024GS 000000410005GS 000000410006GS 000000310003GS 000000310002GS 000000210006GS 000000210007GS 000000210003GS 000000410004GS 000000310001GS 000000010001GS 000000210030GS 000000210008GS 000000410016GS 000000P8059001 000000210027GS 000000410008GS 000000410001GS 000000210017GS 000000210019GS 000000210021GS 000000210020GS 000000310008GS 000000210018GS 000000410014GS 000000210029GS 000000210004GS 000000210001GS 000000210009GS 000000410003GS 000000410013GS 000000210028GS 000000410017GS 000000410015GS 000000310007GS 000000310006GS 000000010005GS
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.
  • Product Description
    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
  • Manufacturer
    GE Healthcare, LLC
Device Recall AdvantageSim MD
  • Model / Serial
    Serial 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  • Product Classification
    Radiology Devices
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MI, MN, MS,MO, NT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, PAKISTAN, NOWAY, NIGERIA, NETHERLANDS, MEXICO, MALAYSIA, LITHUANIA, LATVIA, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, ECUADOR, DOMINICA REPUBLIC, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BRAZIL BELGIUM, AUSTRIA, AUSTRALIA.
  • Product Description
    GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 || Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph
  • Manufacturer
    GE Healthcare, LLC