Events

Rappel de GE Definium 8000

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49388
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1476-2008
  • Date de mise en oeuvre de l'événement
    2007-08-13
  • Date de publication de l'événement
    2008-09-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73238
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Image-intensified fluoroscopic x-ray system. - Product Code JAA
  • Cause
    Necessary certification labels are missing from the x-ray contol.
  • Action
    A field Engineer from GE will visit the customer site to apply label to the X-ray control.

Device

GE Definium 8000
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.
  • Description du dispositif
    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
  • Adresse du fabricant
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA