Device Recall GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.

  • Modèle / numéro de série
    Serial # System ID  00000976624WK7 202884RF2410 00000977748WK3 202884RF2411 00000955594WK7 205877LRF2 00000965983WK0 207373RF1 00000969026WK4 215748LEG1 00000960066WK9 219416ADV 00000975683WK4 228809SR2 00000966338WK6 256235ORF1 00000967770WK9 301896RF 00000961102WK1 302654RF 00000972383WK4 303440BCHRM4 00000964398WK2 303730R3 00000958345WK1 304256RX1A 00000978812WK6 361552LEGD1 00000970377WK8 404321LEG2 00000973016WK9 408259RF1 00000963305WK8 408977RF5 00000963524WK4 414266RM03 00000963118WK5 417533BR2 00000969537WK0 507372LEG 00000959491WK2 518382SRM2 00000976668WK4 540862ARF6 00000966773WK4 561468RM4 00000972380WK0 606285LEGACY 00000966622WK3 619421RF1 00000957841WK0 708216GIRF1 00000983335WK1 713527PRF1 00000964482WK4 775738RM2 00000971676WK2 804289HDF4 00000978181WK6 804747DHP1 00000994573WK4 815740RF1 00000961772WK1 817472LEG1 00000963293WK6 850747ER1 00000975653WK7 856778RF2 00000965747WK9 864295GRRM4 00000973832WK9 904508LEGACY 00000962333WK1 904819RF1 00000970009WK7 907276RM3 00000953103WK9 912633MR3 00000978182WK4 915685ADV3 00000978314WK3 916784LEG 00000977043WK9 936321LEG1 00000963738WK0 941798RM2 00000982588WK6 956388RF1 00000966348WK5 972566RM11 00000962460WK2 RADNETRF130 00000963491WK6 RADNETRF137 00000978497WK6 651232RF4 00000983536WK4 703689RM03 00000011284GP7 210297BMCRF11 00000011281GP3 210297SEBRF3 00000985785WK5 281348P5001 00000014340GP4 308398RF 00000014337GP0 412641RF1 00000984897WK9 435637RM4 00000013713GP3 561863RF1 00000013860GP2 661633XR2 00000014347GP9 713636LBJ7 00000988380WK2 717272RF2 00000011676GP4 720854RF1 00000012513GP8 727823RM3 00000013045GP0 770793P500D 00000012418GP0 781744RF3 00000012521GP1 816348BRF1 00000009196GP7 817255NHPD1 00000013285GP2 828298RF4 00000011737GP4 850325RF4 00000013257GP1 850494WF4 00000014350GP3 856325P500 00000989504WK6 913676SRM4 00000013271GP2 956350VRF3 00000990179WK4 PC7479XR03 00000012826GP4 00105FLU01 00001009797WK0 303825P500 00000009180M31 202745PRE2 00000022650M36 207498P500 00000001835M38 208227ROOM6 00000005813M31 208455RF1 00000002639M33 208678500D 00000022309M39 209536P500 00000015302M33 215710AURORA2 00000002983M35 228377RF10 00000003052M38 228377RF9 00000021223M33 239343RF4 00000021093M30 239432RF11 00000020302M36 240566DF1 00000007194M34 252522LRF1 00000005274M36 256494P5R1 00000992217WK0 260373RF4 00000022744M37 270756P500 00000019347M34 281477MWBP500D 00000008963M31 281637SLSP500D 00000997107WK8 304647PRE 00000022017M38 314251MR2 00000007242M31 314996BW2 00000004648M32 318330RF2 00000008860M39 318473RD4 00000004529M34 337521RF2 00000990537WK3 404325EFL1 00000008599M33 404712GIPR 00000004863M37 404785WBP500D 00000002984M33 406863P500 00000017129M38 412623P500D1 00001001061WK9 414649P500 00000995345WK6 423926RF1 00000017643M38 434654RM4 00000011245M38 469624P500D1 00000019086M38 469764P5001 00000008136M34 484884P500 00000993344WK1 505521RF1 00000020464M34 505609P500 00001004238WK0 509473VR2 00000014498M30 512341RRRF1 00000021219M31 517543P500D 00001003383WK5 540829RF1 00000004233M33 561791RM3 00000011944M36 570824P500 00000004229M31 573468MBS1 00000993783WK0 573756P500 00000005270M34 574523EG2 00000006560M37 574523EG4 00000998427WK9 601288PRF6 00000014272M39 605867P500 00000990547WK2 606678RF2 00001003367WK8 607432GE1 00001003379WK3 607547RF1 00001004242WK2 608745P500 00000021027M38 608775RF500 00000995340WK7 609599RFP4 00000012810M38 609835LMCP500 00001000389WK5 615342P500D3 00000999391WK6 615342P500D4 00000005650M37 617499RF4 00000995344WK9 617732ENDO 00000018235M32 623433RF 00000002217M38 678454P500D1 00000008661M31 702653RF03 00000997661WK4 713359RF3 00000013216M37 713441MOP500DP 00000999916WK0 715847P500 00000018057M30 717270RF2 00000003982M36 717544HCRF6 00001000995WK9 719560RF1 00000002577M35 732840P5D 00000022957M35 740633P500 00000021220M39 757398RM4 00000006859M33 770228RM3 00000021094M38 770400P500D 00000020193M39 785458P500 00000006330M35 802524500D 00000019490M32 812450DRF10 00000998422WK0 812858PRF 00000014501M31 813571RM4 00000020937M39 814723P500 00000001967M39 815741P500 00001004951WK8 815756RM2 00000990278WK4 817255NHRM1 00000020187M31 817782P500 00001007260WK1 864366ARF2 00001003364WK5 864675SFWR2 00000014567M32 910671SERF5 00000008311M33 910907P500RM3 00000021357M39 910938CHP500 00000008197M36 928763WRF1 00001005392WK4 931766RF1 00000023455M39 941629P500 00000010128M37 951CD500 00000022652M32 978741SRF3 00000005653M31 978774RF1 00000991650WK3 JAC3E63 00000020191M33 RADNETRF1284 00000020576M35 RADNETRF1286 00000018006M37 RADNETRF182 00000011818M32 RM7GEP500 00000005493M32 SA2135RX02 00001002438WK8 416813PR500FL1 00000006690M32 IL1000XR06 00000007585M33 00044FLU01 00000007385M38 00065FLU01 00001023876WK4 925947RM2 00001027482WK7 504873TR4P 000000102558K2 337470RF2  00001024517WK3 303RRP5001  00001024518WK1 712362P500  00001024576WK9 815968P500E  00001024577WK7 210617RF1  00001024578WK5 215710AURORA2  00001024725WK2 217443URF5  00001024726WK0 402294EBRF5  00001024741WK9 504837P500  00001024742WK7 501286PRE1  00001024743WK5 225NORF  00001024744WK3 920262P500  00001024874WK8 319268P500  00001024888WK8 937440RM1  00001024889WK6 515295P500  00001025002WK5 541947RF1  00001025003WK3 818364R3  00001025004WK1 606666P500  00001025011WK6 814452P500  00001025012WK4 217732LRF  00001025013WK2 323361R8  00001025055WK3 815431OP500  00001025253WK4 323361RF2  00001025254WK2 216778PREC1  00001025255WK9 509488P500  00001025256WK7 512LRMCRF  00001025366WK4 319272P500  00001025367WK2 ORMCP500  00001025368WK0 501268PRE2  00001025583WK4 337491P500  00001025585WK9 504896P500  00001025586WK7 715532RF  00001025588WK3 812268P500  00001025589WK1 Not Available 00001025590WK9 970870P5001  00001025591WK7 281274WHSLP500D 00001025592WK5 337470RF1  00001025800WK2 630275G04  00001025806WK9 563568P500  00001026022WK2 559459500D  00001026026WK3 970247P500B  00001026240WK0 309691PRF1A  00001026241WK8 631654P500D  00001026242WK6 510814RM4  00001026243WK4 509826MVP500  00001026245WK9 256235P500  00001026246WK7 301765P500  00001026247WK5 508856ORP500  00001026248WK3 918392P500  00001026424WK0 435722P500  00001026425WK7 978368P500  00001026459WK6 806364P500  00001026465WK3 402336P500  00001026466WK1 608364P5002  00001026636WK9 508793MP500  00001026637WK7 318932P500  00001026638WK5 603524500D  00001026639WK3 760873RF2  00001026704WK5 215427DIGRF  00001026705WK2 919RALCPP500M  00001026706WK0 405604P500  00001026970WK2 973579RM2  00001026971WK0 919RALCPP500W  00001026972WK8 417347P500  00001026973WK6 216778PREC2  00001027063WK5 312CMP500D2  00001027079WK1 252847GE3  00001027080WK9 312CMP500D1  00001027081WK7 740845PRE  00001027082WK5 480324P500D  00001027083WK3 918434P500  00001027084WK1 765472P500  00001027085WK8 217333P500D  00001027086WK6 623433RF  00001027087WK4 479549P500  00001027424WK9 402759FCP500  00001027425WK6 305NSHRM5  00001027426WK4 305NSHRM6  00001027483WK5 504896R2P500  00001027484WK3 513870PRE1  00001027485WK0 608258P5002  00001027587WK3 304258RF  00001027588WK1 601798P500  00001027589WK9 859745P500  00001027590WK7 318448RF1  00001027591WK5 913491P500D  00001027592WK3 989246P500  00001027593WK1 614722PRE  00001027594WK9 785243P500  00001027862WK0 715623P500  00001027863WK8 918775P500  00001027864WK6 510372RFP5  00001027866WK1 760957P500D  00001027867WK9 919731WMRF5  00001027868WK7 785458P500  00001028157WK4 816455P500D  00001028158WK2 828213RCRF  00001028159WK0 256486RF1  00001028161WK6 240566DF1  00001028162WK4 FHALTP500  00001028163WK2 828456P500  00001028422WK2 601554P5001  00001028423WK0 336846AMRF  00001028424WK8 404466P500  00001028425WK5 404265P500D1  00001028426WK3 248652P500  00001028632WK6 301295P500A  00001028633WK4 918323P500  00001028634WK2 641228P500  00001028635WK9 775982RF7  00001028822WK3 303673P500D  00001028823WK1 509786P500  00001028824WK9 816554P500D  00001029004WK7 405744OSUVET  00001029005WK4 731644P500  00001029006WK2 573231HCP500  00001029007WK0 217876DRF5A  00001029008WK8 309344MRF1B  00001029134WK2 229353TR3  00001029135WK9 910938CHP500  00001029136WK7 217464P500  00001029137WK5 757398RM4  00001029138WK3 908277P500D  00001029139WK1 240566RHRF1  00001029140WK9 773THOREKP500  00001029226WK6 423877P500  00001029227WK4 916UCD500D  00001029228WK2 865316RF1  00001029425WK4 270725P500  00001029426WK2 314251MR2  00001029427WK0 912681PREC  00001029428WK8 229353TR2  00001029429WK6 434799P500D  00001029430WK4 309467EP500  00001029431WK2 907443P500  00001029432WK0 816795P500D  00001029713WK3 270887RF  00001029714WK1 618798GWP500  00001029715WK8 229391WC1  00001029716WK6 516796P500  00001029717WK4 706554RF1  00001029794WK3 WILMVA500D  00001029837WK0 281540NECCRF  00001029838WK8 479684P500  00001029839WK6 702304RF1  00001030119WK0 530749P500D1  00001030120WK8 423553P500  00001030121WK6 270756P500  00001030122WK4 Not Available 00001030123WK2 301891P500  00001030234WK7 217222QP500  00001030299WK0 269945P500  00001030300WK6 910862P500D  00001030301WK4 Not Available 00001030302WK2 918286P500  00001030303WK0 320845P500  00001030458WK2 309944HH500  00001030459WK0 817865FPSP500  00001030460WK8 615329PP500  00001030461WK6 610284P500  00001030462WK4 937641RMF  00001030580WK3 662OBRF  00001030581WK1 402484AP500  00001030582WK9 229276CRF1  00001030583WK7 Not Available 00001030584WK5 601663P500  00001030634WK8 276988P500  00001030696WK7 361580P500  00001030697WK5 504903P500  00001030699WK1 4083516 00001030700WK7 909796P500  00001030701WK5 269637P500  00001030895WK5 801657P500  00001030896WK3 Not Available 00001030897WK1 808YMP500D  00001030898WK9 303DCIP500  00001030981WK3 Not Available 00001030982WK1 309672P500D2  00001030983WK9 MIMCP500D  00001031089WK4 Not Available 00001031090WK2 Not Available 00001031091WK0 Not Available 00001031092WK8 Not Available 00001031257WK7 Not Available 00001031442WK5 Not Available 00001025587WK5 CANFPRECRX1 00001027088WK2 PC0362XR12  00001026426WK5 GH1042RX02 00001027865WK3 XR1027865WK3 00001030698WK3 XR23354M34 00001028160WK8 YX1285  00001025369WK8 AE1021RX04  00001027096WK5 412372P500D 00001025507WK3 561955RF 00000102474WK4 804287P500  00001024519WK9 203739P500  00001024520WK7 717272RF3  00001024572WK8 405271CCP500  00001024573WK6 650493VARF2  00001024574WK4 281MWP500  00001024575WK1 504842RM3  00001024676WK7 707464RF2  00001024677WK5 Not Available 00001024723WK7 Not Available 00001024724WK5 503623RF1  00001024745WK0 401782SCP500  00001024746WK8 516663RMP5  00001024747WK6 Not Available 00001024748WK4 Not Available 00001024878WK9 605997P500  00001024879WK7 Not Available 00001024880WK5 605747P500  00001024881WK3 605867P500  00001024882WK1 Not Available 00001025005WK8 607547RF2  00001025006WK6 RADNETRF1268  00001025007WK4 757312RM4  00001025008WK2 RADNETRF1269  00001025009WK0 813571RM4  00001025010WK8 RADNETRF1270  00001025049WK6 LLPM500D  00001025050WK4 207564P500  00001025051WK2 315338RF  00001025052WK0 931520P500  00001025054WK6 630275G05  00001025258WK3 985646RF4  00001025260WK9 912367AURORA  00001025261WK7 907PIC2P500  00001025371WK4 918224P500D1  00001025372WK2 818409RF2  00001025373WK0 954JDCHRF1  00001025374WK8 210BMCRF1  00001025375WK5 270251JPRF2  00001025508WK1 508862CCR3  00001025509WK9 212420ENDO1  00001025510WK7 859498P500  00001025511WK5 954JDCHRF2  00001025573WK5 918744P5RM3  00001025574WK3 205408SVRF  00001025575WK0 412623P500D1  00001025576WK8 Not Available 00001025577WK6 407518PRE  00001025578WK4 Not Available 00001025579WK2 719285P500  00001025582WK6 434447CMRM4  00001025876WK2 229P500RF1  00001025877WK0 918744P5RM4  00001025878WK8 606439P500  00001025879WK6 954265ME1  00001025880WK4 518926FLRM4  00001025886WK1 606633P500  00001025887WK9 606237PRE  00001025888WK7 203739RM4  00001025889WK5 269789P500  00001025890WK3 229P500RF2  00001025977WK8 Not Available 00001025978WK6 210MTRF1  00001025988WK5 701252P500  00001026027WK1 434654RM3  00001026028WK9 903CSMP500  00001026029WK7 Not Available 00001026030WK5 559459500D  00001026031WK3 978683LGRF5  00001026146WK9 434654RM4  00001026147WK7 907442KP500  00001026148WK5 704829P500  00001026250WK9 504632P500  00001026251WK7 585596P500  00001026252WK5 208463P500D  00001026253WK3 520GV500D  00001026254WK1 713873P500D  00001026255WK8 727848P5D2  00001026256WK6 727848P5D1  00001026257WK4 936539P500D2  00001026258WK2 Not Available 00001026259WK0 Not Available 00001026260WK8 RADNETRF182  00001026264WK0 781624HSSHRF  00001026467WK9 202269P5003  00001026468WK7 717270RF2  00001026469WK5 409938P500  00001026470WK3 360754ICRF  00001026471WK1 COR481360  00001026472WK9 903GS503  00001026473WK7 406293P500  00001026474WK5 SLRP500FP1  00001026640WK1 541382RM3  00001026641WK9 540SHENP500  00001026642WK7 Not Available 00001026643WK5 561745RM4  00001026709WK4 412623P500D2  00001026710WK2 276228P500  00001026711WK0 Not Available 00001026712WK8 229924P500  00001026713WK6 405752RF2  00001026786WK2 301609P500A  00001026787WK0 631376RM3  00001026788WK8 804893RF1  00001026858WK9 205877BPRF1  00001026859WK7 516256P500  00001026860WK5 850747GC3  00001026861WK3 714827P500  00001026862WK1 509575YMRF2  00001026899WK3 478327P500  00001026900WK9 802885P500D  00001026901WK7 618443SP500  00001026974WK4 912754VIDAR1  00001026975WK1 706651D3  00001026976WK9 501202P500SH  00001026977WK7 631376RM2  00001026978WK5 540CULRF2  00001026980WK1 720SAMOBP500  00001027089WK0 276666P500  00001027090WK8 314577RM7  00001027091WK6 307864P500D  00001027092WK4 307684P500  00001027093WK2 716845DRF1  00001027094WK0 360413P500  00001027095WK7 803751MRF5  00001027097WK3 520CICP500  00001027098WK1 608356P500  00001027237WK5 469764P5001  00001027428WK0 469764P5002  00001027430WK6 949452RM1  00001027431WK4 928348RF2  00001027477WK7 229312FP1  00001027478WK5 520CICP500  00001027615WK2 315425A320  00001027616WK0 812450DRF10  00001027617WK8 281477MWBP500D  00001027618WK6 419933RF  00001027619WK4 704834P500  00001027620WK2 912384RM5  00001027622WK8 MERCYP500R1  00001027854WK7 281274P5DGR  00001027855WK4 503717FP1  00001027856WK2 206598UW213  00001027857WK0 205939SVRF  00001027858WK8 805497RM3  00001027872WK9 937382PRE  00001027873WK7 RADNETRF1284  00001027874WK5 817782P500  00001027875WK2 706356TRF  00001028165WK7 724983500D  00001028166WK5 214820RF3  00001028167WK3 Not Available 00001028168WK1 315363P500  00001028169WK9 505609P500  00001028170WK7 713SCP500D  00001028171WK5 541382CRM1  00001028172WK3 713SCP500D2  00001028430WK5 804SMHOP1  00001028431WK3 270932P500  00001028432WK1 RADNETRF1286  00001028433WK9 718226VZRM3  00001028434WK7 412367P500D2  00001028435WK4 949489RM1  00001028436WK2 740383PRE2  00001028437WK0 SLWP500  00001028601WK1 814723P500  00001028602WK9 RADNETRF183  00001028636WK7 2972752 00001028637WK5 510231P500D  00001028638WK3 608775RF500  00001028639WK1 503VAPRF1  00001028817WK3 RADNETRF1283  00001028818WK1 702383RF6  00001028819WK9 718579RM508  00001028820WK7 239432RF11  00001028821WK5 770400P500D  00001028911WK4 561671RF1  00001028999WK9 517543P500D  00001029001WK3 COMFORTR2  00001029002WK1 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 00001029833WK9 229312MRF1  00001029836WK2 904VACRF  00001030124WK0 229312MRF2  00001030125WK7 231225P500  00001030126WK5 PMCP500  00001030127WK3 RADNETRF1290  00001030128WK1 956632RF2  00001030184WK4 904215RF1  00001030185WK1 408885FL2  00001030186WK9 252847VCH500D  00001030187WK7 816347SLERF  00001030188WK5 209536P500  00001030305WK5 863314P500  00001030306WK3 954587RM4  00001030307WK1 207498P500  00001030308WK9 732294P5D  00001030309WK7 207795P500  00001030310WK5 305HIAP500  00001030415WK2 0004014412A  00001030416WK0 608356P5002  00001030417WK8 270417RF2  00001030463WK2 RADNETRF190  00001030464WK0 830703VVRF1  00001030466WK5 Not Available 00001030467WK3 740633P500  00001030577WK9 618288RM2  00001030578WK7 978741SRF3  00001030579WK5 724772P500D1  00001030704WK9 217383P500A  00001030705WK6 704667RF1  00001030707WK2 501202P500RM2  00001030708WK0 UICGERF1  00001030709WK8 863763RM1  00001030710WK6 478PCHP500  00001030711WK4 Not Available 00001030891WK4 718226VZRM2  00001030892WK2 Not 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwided) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED ARAB EMIRATES and UNITED KINGDOM.
  • Description du dispositif
    GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. || This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F; X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F; and pediatric examinations. The Precision 500D R&F; X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA