• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.
see related information
Date Posted October 17, 2013
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0012-2014
Recall Event ID 66277
Premarket Notification
510(K) Numbers
K011624  K081091  K760466  K801320  K973039 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product 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.
Code Information 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 RADNETRF1287 00001029003WK9 COR481341 00001029144WK1 814624RF2 00001029145WK8 718226PRM10 00001029146WK6 530244P500D 00001029147WK4 313343ERCP 00001029148WK2 404501P500 00001029152WK4 415DAVP500D 00001029153WK2 718226PRM1 00001029231WK6 856355P500 00001029232WK4 856247HWP500 00001029233WK2 631726P500D 00001029234WK0 404686EMRF7 00001029235WK7 Not Available 00001029319WK9 COR481342 00001029320WK7 325670PR7 00001029433WK8 603356P500D 00001029434WK6 215487P500 00001029435WK3 804254RMC 00001029436WK1 541472P500 00001029437WK9 205333FL2 00001029438WK7 COMFORTR3 00001029439WK5 239343RF4 00001029440WK3 MERCYP500R2 00001029558WK2 239432RF14 00001029559WK0 419238P500 00001029560WK8 479587P59 00001029561WK6 441236P500 00001029562WK4 479587P52 00001029708WK3 580379P500 00001029710WK9 205592PRF1 00001029711WK7 209754P500 00001029712WK5 606833P500D 00001029829WK7 937208PRE 00001029830WK5 419228P500 00001029831WK3 205592PRF3 00001029832WK1 620332P500 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 Available 00001030893WK0 505WHRM1 00001030894WK8 408885FL1 00001030985WK4 570621SEPREC 00001030986WK2 941629P500 00001031093WK6 757889RM4 00001031094WK4 937734PRE 00001031095WK1 281420SJM500D1 00001031096WK9 937641RMA 00001031196WK7 910FHHOKE+P500 00001031197WK5 Not Available 00001031198WK3 Not Available 00001031259WK3 Not Available 00001031260WK1 Not Available 00001031312WK0 Not Available 00001031313WK8 Not Available 00001031314WK6 Not Available 00001031315WK3 Not Available 00001031316WK1 Not Available 00010283448WK9 781306RF1 00001027876WK0 910072221 00001027429WK8 752026XR05 00001025262WK5 IE1545RF01 00001028083WK2 A5745526 00001026979WK3 RU3638RX02 00001029000WK5 RU7316RX01 00001029709WK1 RU1279RX03 00001025259WK1 10448FLU03 00001025262WK5 IE1545RF01 00000350013WK9 207647XR1 00000319904WK9 215377RF3 00000330000WK1 580336PRF 00000473802WK7 208227RM2 00000467274WK7 210632RRF 00000440241WK8 316665HR3 00000507540WK3 334277SFX 00000437356WK9 402486MPEX1 00000399552WK9 404589GSF 00000486316WK3 407335RM2 00000459485WK9 410224RF 00000442423WK0 415641ADV 00000420775WK9 601872OR02 00000501994WK8 703776RM2 00000453196WK8 713799TRF 00000481391WK1 804392SCARF1 00000450288WK6 813932SPEC 00000432606WK2 814946RF1 00000516246WK6 919443NDRF1 00000508469WK4 216971R8 00000516440WK5 304257LEG 00000518141WK7 510370RFDG2 00000510617WK4 512476SRM6 00000514169WK2 516968LEG1 00000516439WK7 813681RM3 00000506733WK5 817526MLEG 00000499668WK2 818331SFX 00000512452WK4 847297HF3 00000518883WK4 910249LRF1 00000516878WK6 912633MR1 00000514167WK6 912633MR2 Not Available 519254RM6A 00000530446WK4 209225LEG2 00000521503WK3 315393RF1 00000519118WK4 412578RF9 00000517706WK8 510370RFDG1 00000530677WK4 618253HMRF1 00000523399WK4 718430RM2 00000521501WK7 718430RM3 00000519515WK1 813681SPEC1 00000523405WK9 912751LD 00000551900WK4 228575XR1 00000549174WK1 303778RM6A 00000951422WK5 352351RM2 00000549578WK3 407830RF4 00000546368WK2 414785RM3 00000547501WK7 415923PR5 00000554359WK0 480860RM7 00000554358WK2 480860RM8 00000554360WK8 480860RM9 00000549122WK0 602879RM1 00000552616WK5 603778RM1 00000951884WK6 615769SKYRF3 00000541723WK3 615792RM1 00000553951WK5 618544CMRF1 00000552314WK7 706651D4 00000552929WK2 804541JR2A 00000952157WK6 865693RF3 00000534305WK8 904825LEGACY 00000534304WK1 915595RF4 00000541893WK4 918294SCRF2 00000951254WK2 956632RM1 000000000BJ880 410014XR06 N/A 206386RF1 N/A 212646PREC N/A 281351TLEG N/A 281890MWRF N/A 318448COP2 N/A 404571DL1 N/A 408885LEG1 N/A 512341RRF1 N/A 605665FL N/A 606723XR2 N/A 606836BX3A N/A 610284RF1 N/A 612758RF N/A 616781RF2 N/A 618288ARF2 N/A 702255RF2 N/A 717765RF1 N/A 718667PRM3 N/A 813725RF1 N/A 813432RF1 N/A 815786D5K N/A 906226DMR2 N/A 912273CR1 N/A 931879JRF2 N/A 956721RF1 Not Available 0002872736 Not Available 202745PRE Not Available 203688P500 Not Available 205286BRF Not Available 214345PRF Not Available 254562RF1 Not Available 262OLCGOC1A Not Available 270417RF1 Not Available 407649LG2 Not Available 414777MP2 Not Available 504652RP2 Not Available 573760PR1 Not Available 580251ROOM1 Not Available 601268W5 Not Available 609835P500 Not Available 610284PRO2 Not Available 610284RF3 Not Available 617726RF4E2 Not Available 706754HR2 Not Available 713770THUNDER Not Available 717267RF6 Not Available 815740XRDER Not Available 909GERF1 Not Available 912466P1207 Not Available 928537RM1 Not Available 956632RCR Not Available 973972C308 Not Available DCOSDI000000011 Not Available DCOSDI000000018 Not Available DCOSDI000000222 Not Available DCOSDI000000703 Not Available DCOSDI00001717 Not Available DCOSDI00001740 Not Available DCOSDI00001752 Not Available DCOSDI100000008 Not Available DCOSDI100000043 Not Available DCOSDI100000152 Not Available DCOSDI100000272 Not Available DCOSDI100000412 Not Available DCOSDI100000700 Not Available DCOSDI100000820 Not Available DCOSDI110000289 Not Available DCOSDI140000071 Not Available DCOSDI200000107 Not Available DCOSDI200001358 Not Available DCOSDI300000408 Not Available DCOSDI300000436 Not Available DCOSDI300000440 Not Available DCOSDI300000920 Not Available DCOSDI400000063 Not Available DCOSDI400000167 Not Available DCOSDI50000419 Not Available DCOSDI50000425 Not Available DCOSDI50000426 Not Available DCOSDI600000212 Not Available KPICT Not Available LBDEMO2 Not Available RADNETRF1206 Not Available RADNETRF1213 Not Available RADNETRF1225 Not Available RADNETRF1240 Not Available RADNETRF1254 194130WK1 RADNETRF186 Not Available 416284LS16 Not Available 506648L9A Not Available 514934BRAD3
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p
FDA Determined
Cause 2
TRAINING: Employee Error
Action GE Healthcare sent an "Urgent Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found. 1. If you observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. 2. If plastic grip is secure, but you observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always ON), you may continue to use the device with care. Use all safety precautions relative to application of the myelographic stop and the inhibit, table horizontal stop OFF. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 055 919 For other countries, please contact your local GE Healthcare Service Representative .
Quantity in Commerce 810 (783 US, 27 OUS)
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.
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
510(K)s with Product Code = JAA and Original Applicant = GENERAL ELECTRIC CO.
-
-