Events

Retiro De Equipo (Recall) de Device Recall AdvantageSim MD

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Medical Systems, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    51322
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1718-2009
  • Fecha de inicio del evento
    2009-02-02
  • Fecha de publicación del evento
    2009-08-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79899
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, simulation, radiation therapy - Product Code KPQ
  • Causa
    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.
  • Acción
    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.

Device

Device Recall AdvantageSim MD
  • Modelo / 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.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

Manufacturer

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA