Events

Rappel de Device Recall 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
    49503
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1882-2008
  • Date de mise en oeuvre de l'événement
    2008-03-07
  • Date de publication de l'événement
    2008-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73644
  • 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
    Digital Radiographic System - Product Code KPR
  • Cause
    Radiation dose reading greater than actual dose: error in the generator software on the ge healthcare revolution xr/d configured with hp 8200 pc consoles and all definium 8000 systems may impact patient safety. occasional generator software errors may cause light x-ray images with reported mas readings higher than was actually exposed to the patient using the overhead x-ray tube. the mas rea.
  • Action
    GE sent a Product Safety Notification dated March 7, 2008 to all customers. The letter described the safety issue, affected product, and stated that a GE Healthcare Field Engineer will schedule a field visit to install software updates.

Device

Device Recall GE Definium 8000
  • Modèle / numéro de série
    0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002968M36, 00000003468M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000096383DP5, 00000096401DP5, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000114134VE0, 00000114297VE5, 00000114452VE6, 00000TA41711-6, 00000TA41732-3, 00000TA41827-4, 00000TA41867-8, 00000TA41882-7, 00000TA41896¿4, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA41995-7, 00000TA42004¿5, 00000TA42007-4, 00000TA42020-3, 00000TA42025¿4, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 00001004319WK8, 00001004331WK3, 00001004508WK6, 00001004509WK4, 00001004512WK8, 00001004763WK7, 00001004767WK8, 00001004769WK4, 00001004771WK0, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005021WK9, 00001005023WK5, 00001005025WK0, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005032WK6, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005180WK3, 00001005183WK7, 00001005184WK5, 00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005319WK7, 00001005669WK5, 00001005698WK4, 00001005699WK2, 00001005701WK6, 00001005702WK4, 00001005705WK7, 00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005759WK4, 00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0, 00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005915WK2, 00001006015WK0, 00001006040WK8, 00001006041WK6, 00001006043WK2, 00001006044WK0, 00001006177WK8, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4, 00001006633WK0, 00001006634WK8, 00001006664WK5, 00001006665WK2, 00001006666WK0, 00001006667WK8, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007162WK9, 00001007163WK7, 00001007164WK5, 00001007165WK2, 00001007167WK8, 00001007168WK6, 00001007169WK4, 00001007188WK4, 00001007189WK2, 00001007190WK0, 00001007191WK8, 00001007192WK6, 00001007405WK2, 00001007406WK0, 00001007407WK8, 00001007409WK4, 00001007476WK3, 00001007477WK1, 00001007478WK9, 00001007497WK9, 00001007498WK7, 00001007499WK5, 00001007516WK6, 00001007517WK4, 00001007518WK2, 00001007525WK7, 00001007527WK3, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007533WK1, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007642WK0, 00001007643WK8, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007649WK5, 00001007651WK1, 00001007713WK9, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007721WK2, 00001007776WK6, 00001007777WK4, 00001007778WK2, 00001007779WK0, 00001007779WK0, 00001007780WK8, 00001007781WK6, 00001007782WK4, 00001007783WK2, 00001007784WK0, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008313WK7, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008682WK5, 00001008685WK8, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008807WK8, 00001008808WK6, 00001008809WK4, 00001008810WK2, 00001008811WK0, 00001008812WK8, 00001008814WK4, 00001008816WK9, 00001008835WK9, 00001008837WK5, 00001008838WK3, 00001008839WK1, 00001008840WK9, 00001008841WK7, 00001008842WK5, 00001008843WK3, 00001008995WK1, 00001009057WK9, 00001009058WK7, 00001009059WK5, 00001009060WK3, 00001009061WK1.00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009141WK1, 00001009142WK9, 00001009144WK5, 00001009146WK0, 00001009147WK8, 00001009213WK8, 00001009215WK3, 00001009216WK1, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009221WK1, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009268WK2, 00001009269WK0, 00001009270WK8, 00001009271WK6, 00001009273WK2, 00001009373WK0, 00001009374WK8, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009381WK3, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009532WK1, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009593WK3, 00001009601WK4, 00001009602WK2, 00001009603WK0, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009607WK1, 00001009609WK7, 00001009610WK5, 00001009707WK9, 00001009708WK7, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009714WK5, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009822WK6, 00001009823WK4, 00001009824WK2, 00001009873WK9, 00001009875WK4, 00001009876WK2, 00001009929WK9, 00001009930WK7, 00001009931WK5, 00001009933WK1, 00001009938WK0, 00001009977WK8, 00001009979WK4, 00001009981WK0, 00001009983WK6, 00001009984WK4, 00001009985WK1, 00001010085WK7, 00001010086WK5, 00001010098WK0, 00001010100WK4, 00001010101WK2, 00001010102WK0, 00001010103WK8, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010158WK2, 00001010159WK0, 00001010160WK8, 00001010162WK4, 00001010167WK3, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010239WK0, 00001010240WK8, 00001010241WK6, 00001010242WK4, 00001010243WK2, 00001010291WK1, 00001010293WK7, 00001010296WK0, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010432WK1, 00001010433WK9, 00001010489WK1, 00001010490WK9, 00001010491WK7, 00001010493WK3, 00001010521WK1, 00001010523WK7, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010529WK4, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010628WK4, 00001010630WK0, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010693WK8, 00001010694WK6, 00001010696WK1, 00001010697WK9, 00001010698WK7, 00001010721WK7, 00001010723WK3, 00001010786WK0, 00001010804WK1, 00001010805WK8, 00001010806WK6, 00001010807WK4, 00001010808WK2, 00001010902WK3, 00001010904WK9, 00001010905WK6, 00001010911WK4, 00001010960WK1, 00001010962WK7, 00001010967WK6, 00001011022WK9, 00001011079WK9, 00001011080WK7, 00001011081WK5, 00001011082WK3, 00001011085WK6, 00001011086WK4, 00001011087WK2, 00001011088WK0, 00001011090WK6, 00001011091WK4, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011214WK2, 00001011216WK7, 00001011218WK3, 00001011283WK7, 00001011284WK5, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011385WK0, 00001011386WK8, 00001011387WK6, 00001011389WK2, 00001011449WK4, 00001011450WK2, 00001011700WK0, 00001011703WK4, 00001011712WK5, 00001012286WK9, 00001012453WK5, 00001013134WK0, 00001014310WK5, 00001014936WK7, 00001016147WK9.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Martinique (French), Netherlands, Norway, Palestine, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, and Yugoslavia.
  • Description du dispositif
    GE Healthcare Definium 8000 Digital Radiographic System.
  • 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