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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 Device 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
510(K)Number K051967 
Product Classification Image-intensified fluoroscopic x-ray system. - 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 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 WI 53188-1615
262-544-3894
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
Necessary certification labels are missing from the x-ray contol.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
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.
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