Events

Retiro De Equipo (Recall) de GE Definium 8000

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 Healthcare.

¿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
    49388
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1476-2008
  • Fecha de inicio del evento
    2007-08-13
  • Fecha de publicación del evento
    2008-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73238
  • 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
    Image-intensified fluoroscopic x-ray system. - Product Code JAA
  • Causa
    Necessary certification labels are missing from the x-ray contol.
  • Acción
    A field Engineer from GE will visit the customer site to apply label to the X-ray control.

Device

GE Definium 8000
  • Modelo / Serial
    serial numbers: 0000000002772E, 00000001191M36, 00000002065M31, 00000002650M30, 00000002753EN2, 00000002767EN2, 00000002968M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004547M36, 00000005487M34, 00000096383DP5, 00000097656DP3, 00000100740WK6, 00000114297VE5, 00000989905WK5, 00000992237WK8, 00000992321WK0, 00000992949WK8, 00000992952WK2, 00000993284WK9, 00000993807WK7, 00000994376WK2, 00000994685WK6, 00000994845WK6, 00000995791WK1, 00000995797WK8, 00000995798WK6, 00000995799WK4, 00000996181WK4, 00000996289WK5, 00000996290WK3, 00000996629WK2, 00000996739WK9, 00000996745WK6, 00000996977WK5, 00000997197WK9, 00000997198WK7, 00000997265WK4, 00000997333WK0, 00000997803WK2, 00000997808WK1, 00000997809WK9, 00000997885WK9, 00000997887WK5, 00000998455WK0, 00000998632WK4, 00000TA42184-1, 00001001026WK2, 00001001592WK3, 00001003410WK6, 00001003576WK4, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004158WK0, 00001004163WK0, 00001004330WK5, 00001004331WK3, 00001004332WK1, 00001004504WK5, 00001004770WK2, 00001004771WK0, 00001004772WK8, 00001004884WK1, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005020WK1, 00001005021WK9, 00001005022WK7, 00001005023WK5, 00001005024WK3, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005030WK0, 00001005031WK8, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005181WK1, 00001005184WK5, 00001005188WK6, 00001005260WK3, 00001005698WK4, 00001005757WK8, 00001005762WK8, 00001005764WK4, 00001005841WK0, 00001005912WK9, 00001006015WK0, 00001006040WK8, 00001006043WK2, 00001006044WK0, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006474WK9, 00001006475WK6, 00001006476WK4, 00001006633WK0, 00001006637WK1, 00001006664WK5, 00001006666WK0, 00001006668WK6, 00001006822WK9, 00001006833WK6, 00001006871WK6, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007161WK1, 00001007162WK9, 00001007165WK2, 00001007166WK0, 00001007192WK6, 00001007476WK3, 00001007478WK9, 00001007498WK7, 00001007499WK5, 00001007517WK4, 00001007525WK7, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007563WK8, 00001007642WK0, 00001007643WK8, 00001007644WK6, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007651WK1, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007776WK6, 00001007781WK6, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007907WK7, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008312WK9, 00001008313WK7, 00001008314WK5, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008684WK1, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008811WK0, 00001008813WK6, 00001008814WK4, 00001008840WK9, 00001008995WK1, 00001009057WK9, 00001009059WK5, 00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009140WK3, 00001009142WK9, 00001009144WK5, 00001009145WK2, 00001009147WK8, 00001009213WK8, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009269WK0, 00001009271WK6, 00001009273WK2, 00001009374WK8, 00001009375WK5, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009380WK5, 00001009381WK3, 00001009382WK1, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009609WK7, 00001009707WK9, 00001009708WK7, 00001009709WK5, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009823WK4, 00001009876WK2, 00001009930WK7, 00001009931WK5, 00001009938WK0, 00001009976WK0, 00001009977WK8, 00001009979WK4, 00001010086WK5, 00001010098WK0, 00001010101WK2, 00001010102WK0, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010159WK0, 00001010161WK6, 00001010162WK4, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010240WK8, 00001010243WK2, 00001010291WK1, 00001010292WK9, 00001010293WK7, 00001010295WK2, 00001010296WK0, 00001010297WK8, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010431WK3, 00001010432WK1, 00001010433WK9, 00001010488WK3, 00001010489WK1, 00001010490WK9, 00001010521WK1, 00001010523WK7, 00001010524WK5, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010629WK2, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010695WK3, 00001010696WK1, 00001010723WK3, 00001010804WK1, 00001010904WK9, 00001010906WK4, 00001010907WK2, 00001010908WK0, 00001010962WK7, 00001011079WK9, 00001011081WK5, 00001011085WK6, 00001011086WK4, 00001011088WK0, 00001011091WK4, 00001011092WK2, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011215WK9, 00001011218WK3, 00001011219WK1, 00001011283WK7, 00001011284WK5, 00001011285WK2, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011289WK4, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011387WK6, 00001011388WK4, 00001011389WK2, 00001011449WK4, 00001011452WK8, 00001011454WK4, 00001011485WK8, 00001011486WK6, 00001011488WK2, 00001011489WK0, 00001011490WK8, 00001011491WK6, 00001011494WK0, 00001011495WK7, 00001011496WK5, 00001011630WK9, 00001011631WK7, 00001011632WK5, 00001011633WK3, 00001011634WK1, 00001011635WK8, 00001011643WK2, 00001011648WK1, 00001011654WK9, 00001011697WK8, 00001011700WK0, 00001011703WK4, 00001011715WK8, 00001011716WK6, 00001011821WK4, 00001011822WK2, 00001011824WK8, 00001011825WK5, 00001011826WK3, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011830WK5, 00001011831WK3, 00001011832WK1, 00001011926WK1, 00001011928WK7, 00001011962WK6, 00001012011WK1, 00001012012WK9, 00001012013WK7, 00001012014WK5, 00001012015WK2, 00001012117WK6, 00001012118WK4, 00001012119WK2, 00001012120WK0, 00001012121WK8, 00001012122WK6, 00001012164WK8, 00001012165WK5, 00001012173WK9, 00001012278WK6, 00001012280WK2, 00001012284WK4, 00001012285WK1, 00001012299WK2, 00001012428WK7, 00001012429WK5, 00001012430WK3, 00001012450WK1, 00001012452WK7, 00001012593WK8, 00001012594WK6, 00001012622WK5, 00001012923WK7, 00001012925WK2, 00001012927WK8, 00001012928WK6, 00001012929WK4, 00001012930WK2, 00001012931WK0, 00001013005WK2, 00001013025WK0, 00001013064WK9, 00001013100WK1, 00001013101WK9, 00001013136WK5, 00001013143WK1, 00001013145WK6, 00001013222WK3, 00001013223WK1, 00001013224WK9, 00001013225WK6, 00001013305WK6, 00001013306WK4 , 00001013334WK6, 00001013335WK3, 00001013336WK1, 00001013337WK9, 00001013621WK6, 00001013622WK4, 00001015809WK5, 00002UA5040SGX, 00002UA52707GV.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.
  • Descripción del producto
    GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
  • Manufacturer
    GE Healthcare

Manufacturer

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