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U.S. Department of Health and Human Services

Class 2 Device Recall GE Definium 8000

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 Class 2 Recall
GE Definium 8000
see related information
Date Posted September 18, 2008
Recall Status1 Terminated on October 07, 2010
Recall Number Z-1476-2008
Recall Event ID 49388
Premarket Notification
510(K) Numbers
K011624  K051967 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
Code Information 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, 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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,
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Necessary certification labels are missing from the x-ray contol.
FDA Determined
Cause 2
TRAINING: Employee Error
Action A field Engineer from GE will visit the customer site to apply label to the X-ray control.
Quantity in Commerce 448
Distribution Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = JAA and Original Applicant = GE MEDICAL SYSTEMS
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