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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Legacy

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  Class 2 Device Recall GE Healthcare Legacy see related information
Date Initiated by Firm November 21, 2016
Create Date December 23, 2016
Recall Status1 Terminated 3 on September 26, 2017
Recall Number Z-0909-2017
Recall Event ID 75851
510(K)Number K862120  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Legacy
Code Information  Mfg. Lot or Serial # System ID 00000118203MO9 256235ORF1 00000118220MO3 256235ORF2 00000100096MO7 205655LRF 00000080072YY2 205783LRF2 00000119875MO3 205930LRF Not Available 205801KRF4 00000026146YY1 205793FLEG 00000047927YY9 205793FR1 00000089624MO1 205877LRF2 00000047907YY1 205534RM2 00000094699MO6 256517EF2 00000089628MO2 256534RM1 00000113953MO4 205387LRF 00000034291YY5 334293JLD3 00000063480YY8 256386LD1 00000063481YY6 256386LD2 00000119881MO1 205345RF3 00000119916MO5 205554VAL 00000128623MO6 479553RF2 00000118229MO4 501520RF1 00000100110MO6 501622SJR4 00000071209YY1 501751NWX2 00000146291MO0 520432RM1 00000063528YY4 480264RF1 00000119856MO3 480821RM2 00000119873MO8 480821RM2 00000128466MO0 928729RM4 00000128464MO5 928729RM5 00000071297YY6 602588LEGACY 00000128589MO9 602588ROOM5 00000063529YY2 602856LEG 00000063617YY5 602835RM2 00000118196MO5 602835RM3 00000118194MO0 602239RMF 00000063638YY1 602879RM1 00000128507MO1 623445LEG 00000119871MO2 623879RM3 00000071252YY1 602994DRS 00000094664MO0 520742LEGACY 00000071291YY9 520742RM1 00000119898MO5 520872RM3 00000023695YY0 619242RF3 00000100087MO6 209386ATWRF 00000063549YY0 661282XR 00000063581YY3 650696M6 00000071217YY4 619725RM4 00000146295MO1 818884LRF1 00000063461YY8 916537MXF Not Available 209992CP1 00000026093YY5 818331SFX 00000023850YY1 707443JR5 00000022135YY8 209221TCX 00000100070MO2 831395RF2 00000153568M01 858626RF6 00000153565M07 858626RF7 00000128636MO8 925734RF1 00000113872MO6 RADNETRF130 00000063584YY7 323669ADV 00000047971YY7 209225LEG3 00000052191YY4 336835HCR1 00000031396YY5 510370RFDG2 00000047998YY0 510372RF2 00000052100YY5 510372RF2 00000080068YY0 209577LEG 00000119878MO7 RADNETRF138 00000052169YY0 RADNETRF174 00000026132YY1 619485RM3 00000119892MO8 909788LF3 00000118227MO8 909788LF4 00000026094YY3 916423AVTX2 00000071284YY4 480860RM10 00000022205YY9 1443 00000094667MO3 619487RF1 00000146280MO3 619543RF4 00000063775YY1 415923LEGACYGI 00000071207YY5 415387C1 00000063587YY0 415387C2 00000047912YY1 415821SF1X28 00000063612YY6 415923PR5 00000031389YY0 408947LEGACY 00000113904MO7 408977RF5 00000071242YY2 RADNETRF122 00000031430YY2 707838SFX 00000031377YY5 707423TC Not Available 707648KVRF1 Not Available 805648RM5 00000071200YY0 916662XF2 00000052168YY2 303695ROOM3 00000052165YY8 303695ROOM4 00000128486MO8 303440BCHRM4 00000089644MO9 303659RF1 00000031365770 719776RM5 00000039662YY2 303778RM3A 00000128577MO4 303398RF 00000022143YY2 303788RM9 00000128582MO4 303699RF2 00000128511MO3 303450RM2 00000063707YY4 860585RM3 00000153573MO1 203797LEG1 00000063670YY4 860358RF2 00000063518YY5 703697RF2 00000063501YY1 407830RF4 00000063503YY7 863533RM1 00000113913MO8 941798RM2 00000146285MO2 941798RM3 00000031454YY2 813681SPEC1 00000031395YY7 407566CH2 00000048093YY9 352394LG1 00000034296YY4 407434RF1 00000100099MO1 352689RF 00000128504M08 850883ER5 00000119904MO1 239931RM2 00000118228MO6 561468RM4 00000071205YY9 850862FR3 00000113905MO4 954985ME11 00000113880MO9 954987MOP4 00000146302MO5 352344RFLEG 00000128526MO1 239369RM3 00000034273YY3 407434RF2 00000063769YY4 850626SR4 00000119860MO5 NCHRFRM3 Not Available 813462RF1 00000071282YY8 352351RM2 00000119940MO5 352861RF1 00000052121YY1 904264LEGACY 00000052185YY6 407896RF5 00000039674YY7 904672LGY1 00000031333YY8 561622RF1 00000031361YY9 561622RF2 00000128472MO8 FHFGRF1 00000113895MO7 850747BMC1 00000113896MO5 850747ER1 Not Available 904769BRA2 00000071226YY5 850111RF1 00000128533MO7 321752WLG1 00000063496YY4 727845RF2 00000048016YY0 813725RF2 00000113874MO2 904819RF2 00000063782YY7 727825RM9 00000128482MO7 RADNETRF144 00000063778YY5 850325RF1 00000063708YY2 850656RF2 00000119888MO6 954724LEG 00000119876MO1 813828RF2 00000128592MO3 813872LEG1 00000071260YY4 941483RM2 00000023844YY4 407646RF6 00000048003YY8 770603LEG1 00000146293MO6 404459MMLEG 00000034230YY3 404851LEG1 00000031331YY2 404851LEG3 00000047923YY8 404851LEG5 00000100088MO4 404851STJOEL1 00000047930YY3 912246MR3 00000031346YY0 770382WCRF 00000031385YY8 404571DL2 00000119920MO7 404321LEG2 00000118209M06 706754HR2 00000119917MO3 478277VAR2 00000080089YY6 478633R3 00000047996YY4 478633R4 00000113914MO6 912757RF2 00000063507YY8 912327LD3 00000039672YY1 770677LEG1 00000034289YY9 912356LEG2 00000031358YY5 912386TR1 Not Available 912386TR5 00000026108YY1 404867BRF1 00000128451MO2 712476LEG 00000022131YY7 708259NWTC Not Available 312567PR6 00000031341YY1 847297HF3 00000119889MO4 815284RM2 00000063589YY6 847570RF6 00000031335YY3 309343CRF4 00000026110YY7 630858GLD 00000094668MO1 847657GR4 00000034266YY7 618664URF2 00000063691YY0 708216GIRF1 00000026150YY3 708216L12 Not Available 708681WRF1 00000047940YY2 309347PRF1 00000113871MO8 309655FNCRF1 00000089648MO0 309655FXF11 00000063672YY0 217788LEG2 00000022211YY7 217544JRMF 00000031336YY1 217544RMI 00000128639MO2 864560BJWR1 00000071294YY3 217337CXF2 00000031307YY2 217383CRF1 00000119891MO0 847360RF1 00000119909MO0 812256RF2 00000034229YY5 765827LEG 00000094704MO4 219416ADV 00000128568MO3 260425SJRF6 00001285568MO3 260425SJRF6 00000128581MO6 317621LEGACY 00000063559YY9 812482LRF Not Available 317662RM5 00000094693MO9 219284RM4N 00000100090MO0 219284RM5N 00000119901MO7 812237TH3 00000089620MO9 913684MLEG 00000128456MO1 620223MRF 00000113902MO1 913596PR3 00000146287MO8 316759LEGACY 00000047986YY5 913317SRM2 00000047999YY8 913317SRM3 00000026134YY7 913345MLEG1 00000048048YY3 316672PD1 00000128510MO5 785472RF 00000128542MO8 785743TRF 00000113958MO3 502348RF1 00000023691YY9 502781G2 00000031486YY4 606439LEG 00000031465YY8 606252RF5 00000063582YY1 414785RM3 00000052134YY4 606268FL2 00000128459MO5 859226RF2 00000119913MO2 859255RF1 00000080086YY2 502636AF1 00000118215MO3 502933RF1 00000128477MO7 606285LEGACY 00000113870MO0 606987LEG1 00000128469MO4 606354PRSN 00000080085YY4 502622RF1 00000089612MO6 606451LEG1 00000119899MO3 606365RF1 00000071283YY6 318473RD2 Not Available 318448COP1 00000119852MO2 985748RF Not Available 225769RF1 00000118207MO0 504898HC2 00000023720YY6 318531FRM4 00000071253YY9 225222LEG 00000146312MO4 985652LEG 00000128611MO1 985882RF1 00000128619MO4 318253LEG 00000119931MO4 504885LEG Not Available 504885RF1 00000023768YY5 318377MR3 00000063495YY6 318327RM7 00000026096YY8 318327RM8 00000128513MO9 318327RM9 00000026099YY2 318327SFCH2 00000048035YY0 318335RF2 00000094656MO6 318728RF1 Not Available 318255GRM1 00000119859MO7 225635RF1 00000034218YY8 318227SRM5 00000034225YY3 318675LR8 00000022216YY6 318798HR3 00000034268YY3 318798HRM4 00000048047YY5 318539LEG 00000128461MO1 504391RF1 00000128460MO3 504391RF2 00000031309YY8 318329GRM6 00000113915MO3 318435RF1 00000023749YY5 617355RF1 Not Available 617754RM2 00000022197YY8 617499RM3 00000071203YY4 978287ERF1 00000063813YY0 508548TC4 00000052179YY9 978796DEV 00000052123YY7 301981RF5 00000128508MO9 443849RF1 00000119851MO4 301896RF 00000128519MO6 301896RF1 00000063764YY5 410392R2 Not Available 301762RF1 00000022175YY4 301279RF2 00000080099YY5 301681RF 00000094687MO1 207262SRF3 00000094689MO7 207262SRF3 00000118199MO9 207373RF1 00000146279MO5 207255RF2 00000128642MO6 231547ADV 00000113876MO7 810421RF 00000063737YY1 248937LEG 00000146322MO3 313593LEG1 00000153564MO0 313593LEG2 00000113929MO4 313745RF4 00000128547MO7 FHEOLG1 00000113946MO8 517353LEGACY 00000089651MO4 517663LEGACY 00000100081MO9 616391LEGACY 00000100108MO0 989348DRS1 00000128505MO5 517545LEG 00000031393YY2 906524ADV1 00000063777YY7 517353DNR 00000128448MO8 517332LEGACY 00000128550MO1 231845RMB 00000063465YY9 248551RM12 00000113890MO8 517583HRF1 Not Available 734429F1 00000119893MO6 989362DRS1 00000153570MO7 313295LEG 00000071277YY8 507345LEG 00000022203YY4 319352WR2 00000023725YY5 612520N7 00000113942MO7 507332RF 00000063516YY9 651565RF 00000080094YY6 651232SM 00000119894MO4 507372LEG 00000094659MO0 417623FEL 00000023690YY1 816932SR7 00000113954MO2 314625SJW2 00000146320MO7 417235CMRF 00000023742YY0 314577USHRF1 00000146289MO4 417269NX4 00000047984YY0 417885SXL1 00000128574MO1 636239JRF5 00000100111MO4 636327CRL 00000047994YY9 601244OPRF1 00000118223MO7 601933LEG 00000048041YY8 228575XR1 00000071220YY8 228575XR2 00000071248YY9 228575XR3 00000128522MO0 601268W6 00000119862MO1 601364ARF3 00000034235YY2 601376LEG 00000128457MO9 601968COLRF1 00000146296MO9 601968LEG1 00000146282MO9 601968LEG2 00000023696YY8 601684SFX 00000146274MO6 318336LEG 00000128583MO2 228809SR2 00000118240MO1 662324RF1 00000118234MO4 601883RF1 Not Available 601636RF2 00000128524MO6 601735RF2 00000031380YY9 406563A03 00000031476YY5 406543SX2 00000063814YY8 828213MMR1 00000052154YY2 828255SJR5 00000071223YY2 919575XR50 00000063774YY4 704384RF2 00000094663MO2 704543GERF1 00000071240YY6 828452RF1 00000063472YY5 919684RM13 00000063460YY0 919684RM14 Not Available 919684EN3 00000026148YY7 910609HSLEG 00000119872MO0 828322CLEG3 00000071232YY3 919522LRF2 00000039658YY0 910249LRF1 00000113923MO7 919497LEG 00000047950YY1 336719NR151 00000094692M01 910215LEG2 00000094692MO1 910215LEG2 00000023706YY5 919733ADV Not Available 919783RADV 00000031343YY7 919443NDRF2 00000118221MO1 919934JADV1 00000118218MO7 919934JADV2 00000113879MO1 252641HRLEG 00000118214MO6 910642CRLEG 00000031339YY5 910343NHR8 00000094691MO3 910452CFR2 00000100097MO5 402481RF2 00000063642YY3 603778RM2 Not Available 603332FRFSF Not Available 801408ENDO 00000128528MO7 732321LEG6 00000039675YY4 908527RF3 00000039670YY5 908527RF4 00000118210MO4 908351RF 00000031398YY1 908821LEG 00000071225YY7 73222215 00000119942MO1 973365RM5 00000119865MO4 973971PED2 00000128498MO3 973972C309 00000080079YY7 973365RM4 00000034295YY6 201754LEG 00000047929YY5 201754RF6 00000047948YY5 201754RF8 00000146300MO9 973977TILTC 00000113948MO4 732442LEG 00000128629MO3 973831RF3 00000052166YY6 505841RM2 00000128470MO2 505722XRM1 00000052183YY1 505287ADVTX 00000128501MO4 505492RF1 00000128489MO2 505522RF1 00000128496MO7 RADNETRF146 00000071288YY5 702564RF1 00000118226MO0 702731SRF13 00000118225MO2 702731SRF7 00000031371YY8 516968LEG1 00000047954YY3 516968LEG2 00000034244YY4 718430RM3 00000048029YY3 718250LEGACY 00000022173YY9 718780RM2 00000023672YY9 718780RM4 00000063531YY8 718940LEGACY Not Available 718780RM1 00000119926MO4 585393VRF2 00000031392YY4 718738RF 00000063723YY1 718883RF2 00000063724YY9 718883RF3 00000063452YY7 315764MRF1 00000063732YY2 914666DRS 00000063564YY9 212463LEGACY 00000034261YY8 315393RF1 00000023837YY8 516474LEGACY 00000048039YY2 631476RM1 00000089647MO2 516766RF 00000063702YY5 518583RF2 00000128458MO7 740425RF1 00000063800YY7 513686LEG 00000063489YY9 937268RM120 Not Available 614446HX4 00000071259YY6 419227RM2 00000113899M09 330837R4 00000063701YY7 740393LEG2 00000128590MO7 419698RF1 00000128549MO3 419698RF2 00000113945MO0 419734LEGACY 00000128616MO0 330332R18 00000048033YY5 4194475 00000071233YY1 330841R5 00000100084MO3 740454RF3 00000048095YY4 580421VRF1 00000071245YY5 405359ER3 00000039684YY6 918682MRF2 00000128618MO6 405307NRF2 00000048079YY8 405271URF2 00000063509YY4 405636SRF6 00000048064YY0 918294SCRF3 00000063511YY0 918294SCRF2 00000119890MO2 580772RF1 00000113886MO6 580256WRF1 00000118222MO9 405717CVRF1 00000063513YY6 541677MOR3 00000023698YY4 215776LRF3 00000063652YY2 717267RF6 00000026162YY8 610826FL2 00000023838YY6 215221CL1 00000034254YY3 215707LEGACY 00000128471MO0 412624F1 00000034293YY1 717340LD2 00000047955YY0 610378RF5 00000063605YY0 610988RF6 Not Available 215881RF1 00000071201YY8 401274WILEG 00000128565MO9 401737KLEG 00000063710YY8 401596WLEG 00000031399YY9 864716RM2 00000052153YY4 843674RF3 00000052152YY6 843674RF4 00000119877MO9 864487UPR2 00000113906MO2 843527GRF4 00000118233MO6 864255SFOP3 00000118232MO8 864255SFOP4 00000118195MO7 864295GRRM4 00000063544YY1 843293RF 00000048019YY4 605352LEG 00000071228YY1 507537LEG 00000047938YY6 423493PRF3 00000023682YY8 423495MX10 Not Available 423495MX15 00000052192YY2 901853RF1 00000052198YY9 901853RF2 00000031349YY4 901285RA 00000063546YY6 901754G1 00000023769YY3 901757R4 00000128576MO6 423636RF 00000071296YY8 615264H4 00000063773YY6 731425GI 00000094678MO0 901424RF1 00000047997YY2 423837GRF1 00000094698MO8 423857RF5 00000026174YY3 615473RRF 00000034279YY0 901369GE1 00000119849MO8 901384OPRF 00000063610YY0 901523VA5 00000063648YY0 901523VA7 00000031348YY6 901726M21 00000031485YY6 615781LEG 00000071214YY1 615769SKYRF3 00000071212YY5 615769SKYRF5 00000071285YY1 615769SKYRF7 Not Available 615356RM2 00000128584MO0 865481RF3 00000063614YY2 931967SRF 00000063536YY7 512660RF1 00000071289YY3 806355RM2 00000100098MO3 817472LEG1 00000113885MO8 817472LEG2 00000146284MO5 512314AS1 00000146318MO1 512448PORF 00000031327YY0 512476SRM6 00000034267YY5 409838ORF 00000052190YY6 409838ORF2 Not Available 409842BRF 00000128490MO0 903583VADIG 00000034221YY2 903583VAL 00000080065YY6 409680BVPRF1 00000119914MO0 979776SJRF1 00000031475YY7 409764BE6 00000128570MO9 361985RF2 00000094677MO2 903654RF1 00000039677YY0 972376VARF1 00000023673YY7 401354 00000113931MO0 214820RF1 00000080088YY8 214827RF 00000094695MO4 214947RF4 Not Available 401353 00000063735YY5 940898ENDO 00000146315MO7 956388RF1 00000052144YY3 915533RF1 00000052126YY0 915595RF4 00000063675YY3 817882ENDO 00000071263YY8 817551HMLEG4 00000063629YY0 INSIGHTXR041 00000119874MO6 956389RF5 00000022070YY7 713527PRF 00000128480MO1 281618LEG 00000113965MO8 713455LEG1 00000113959MO1 713455LEG4 00000146301MO7 713527PRF1 00000113884MO1 409539LEG2 00000052131YY0 817498LEG 00000031374YY2 972751RF 00000146297MO7 281599LEG 00000128512MO1 806725B1 00000128525MO3 806725B2 00000119854MO8 806792LSRF4 00000119857MO1 806792RF10 00000128638MO4 856346RF Not Available 956632RM1 00000063809YY8 972548ENDO 00000063810YY6 972548ENDO 00000052141YY9 972548RF2 00000052151YY8 972548RF3 00000089630MO8 214320RF1 00000128637MO6 915685ADV3 00000048075YY6 817255NHLEG 00000026083YY6 915334LEGACY 00000089642MO3 806435RF1 00000063745YY4 972596GI 00000063748YY8 972596GI 00000128569MO1 361552LEGD1 00000047943YY6 210575CRF2 00000146288MO6 210614NRF1 00000119869MO6 210614NW1 00000128532MO9 210614RF1 00000146314MO0 210614SRF1 00000063510YY2 210704SRP1 00000113932MO8 210705SRMC4 00000146305M08 817424GEXR1 00000071281YY0 409938ADTX2 00000128562MO6 936321LEG1 00000128575MO8 936321LEG2 00000128463MO7 907353RM3 00000080064YY9 281338CL5 00000128606MO1 435587RM1 00000023757YY8 801581RM7 00000128599MO8 571223RF 00000048034YY3 540236ARF1 00000071222YY4 804541JR2A 00000113878M03 804861FDOC 00000113878MO3 804861FDOC 00000128596MO4 540862ARF6 00000063603YY5 540743RF 00000063464YY2 757886RM3 00000023818YY8 804466RM10 00000063607YY6 757671RM1 00000031443YY5 540546ARF 00000047947YY7 703478RF 00000071204YY2 703689RM02 00000128453MO8 804289HDF4 00000128631MO9 804747DHP1 00000128585MO7 804747HDP4 00000119919MO9 540462ARF 00000063754YY6 434447CMRF1 000000128520O4 757673RM1 00000119848MO0 757934RM6 00000128626MO9 757363RM3 00000022196YY0 206385RM1 00000063532YY6 509924VL 00000094690MO5 425883FLUORO1 00000094700MO2 509575PYX4 00000063742YY1 864261RM15 00000146321MO5 512454CNTRF 00000113963MO3 310289LEGACYD 00000048057YY4 419354LEGACY 00000052186YY4 781273L2 00000128479MO3 406782SX3 00000094688MO9 717SHCRF1 00000128500MO6 662627RF4 00000039688YY7 214376VARF2 00000034203YY0 214345PRF 00000113968MO2 859236RF2 00000153567MO3 DELANO2LEG1 00000023708YY1 313576RM3611 00000048072YY3 580251DSP 00000031359YY3 610250FL2 00000063550YY8 409772TDC1 00000031367YY6 864675SFWLEG 00000063462YY6 601268W5 00000048070YY7 713442KDRF2 00000063494YY9 713455LEG 00000113899MO9 330837R4 00000146290MO2 414963RF1 00000048088YY9 414266RM5 00000048077YY2 414289GI1 00000146303MO3 414527ADV1 00000100072MO8 510869LEG6 00000119903MO3 732970LEGACY 00000063524YY3 913676SR9 00000047972YY5 941629RF2 00000022100YY2 414636ENDO1 00000100082MO7 262321RF1 00000071234YY9 262687RF112 00000063643YY1 414636LEG6 00000100105MO6 RADNETRF129 00000048020YY2 904825LEGACY 00000052116YY1 210575CRF1 00000100106MO4 805739LG 00000100109MO8 707576RF3 00000113917MO9 707576RF1 00000022110YY1 715346TC1 00000063519YY3 409822TRF 00000071229YY9 580421VRF1 00000071219YY0 281218HSLXXX 00000048046YY7 940764RMCXXX 00000071271YY1 570829RF4VA 00000052140YY1 630682CDH4 00000094673MO1 304256RX1A 00000146294MO4 304256RX3A 00000063450YY1 304348SX2 00000128481MO9 304462LEG 00000119858MO9 304424RF1 00000089613MO4 304235WX1B 00000063711YY6 307332RF 00000113937MO7 307332RF 00000089652MO2 780624RF 00000063705YY8 306778RF1 00000113881MO7 EG1112RX07 00000026208YY9 GOLD001109 00000026123YY0 HC0887XR01 00000063557YY3 XR545633WK0 00000063682YY9 0850080428 00000048038YY4 0850080430 00000052119YY5 0530867LEG 00000048068YY1 RU1556RX03 00000048074YY9 RU1488RX13 00000063538YY3 RU1488RX14 00000048078YY0 RU1488RX17 00000048076YY4 RU1488RX19 00000022086YY3 YU1001VA02 00000031418YY7 AE1009RX01 
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Stephanie Cass
Manufacturer Reason
for Recall
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Consignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce Total for all products 1,598 (USA 824, OUS 774)
Distribution US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GENERAL ELECTRIC CO.