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

Class 1 Device Recall Infinia

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

New Search Back to Search Results
 Class 1 Recall
see related information
Date Posted July 24, 2013
Recall Status1 Open
Recall Number Z-1787-2013
Recall Event ID 65579
Premarket Notification
510(K) Numbers
K022960  K052434  K991841 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Code Information System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 0850260114, 0850260115, 0850260117, 0850260119, 0850260120, 0850260121, 0850260123, 0850260124, 0850260127, 0850260129, 0850260130, 0850260133, 0853260020, 0853260023, 0853260024, 0853260025, 0853260029, 0853260030, 0853260032, 0853260035, 0853260036, 0853260039, 0853260040, 0853260042, 0853260045, 0853260046, 0853260056, 0853260062, 0853260066, 0853260069, 0853260072, 0853260074, 0853260087, 0853260100, 0853260103, 0853260105, 0853260113, 853260118, 0853260119, 0856260023, 0856260024, 0856260025, 0856260026, 0856260028, 856260029, 0856260030, 0856260031, 0856260032, 859260010, 0910262170, 0910262196, 0910262205, 0910262210, 0910262214, 0910262217, 0910262220, 0910262225, 0910262227, 0910262229, 0910262234, 0910262236, 0910262239, 0910262241, 0910262244, 0910262249, 0910262255, 0910262257, 0910262263, 0910262266, 0910262269, 0910262276, 0910262279, 0910262280, 0910262285, 0910262288, 0910262291, 0910262293, 0910262295, 0910262301, 0910262307, 0910262312, 0910262332, 0910262335, 0910262338, 910262349, 0910263135, 0910263143, 0910263157, 0910263159, 0910263161, 0910263166, 0910263190, 0910263198, 0910263204, 0910263207, 0910263210, 0910264058, 0910264060, 0910264062, 0910264067, 0910264069, 0910264072, 0910264075, 0910264077, 0910264079, 0910264081, 0910264083, 0910264085, 0910264089, 0910264091, 0910264095, 0910264098, 0910264100, 0910264102, 0910264105, 0910264107, 0910264112, 0910264115, 0910264121, 0910264123, 0910264126, 0910264129, 0910264136, 0910264137, 0910264145, 0910264152, 0910265050, 0910265053, 0910265055, 0910265059, 0910265063, 0910265066, 0910265068, 0910265072, 0910266042, 0910266045, 0910266050, 0910266053, 0910266063, 0910266067, 0910267010, 0910267015, 0910267020, 0920269079, 0920269081, 0920269082, 0920269087, 0920269092, 0920269093, 082426010014, 082426020005, 082426030020, 082426030021, 082426030022, 082426040030, 082426040033, 082426040034, 082426040035, 082426040036, 082426040037, 082426040038, 082426040039, 082426040041, 082426040042, 082426040045, 082426040048, 082426040049, 082426040050, 082426050004, 082426050005, 082426050007, 082426070018, 082426070019, 082426070020, 082426070022, 082426070023, 082426070024, 082426070025, 082426070033, 082426080010, 082426080012, 082426080014, 082426080018, 082426080019, 082426090016, 082426090017, 082426090018, 082426090020, 082426090021, 082426090022, 082426090023, 082426090024, 082426090026, 082426090027, 082426090028, 082426090033, 082426100028, 082426100032, 082426100033, 082426100035, 082426100036, 082426100037, 082426100038, 082426100041, 082426100043, 082426100044, 082426100046, 082426100047, 082426100048, 082426110004, 082426110006, 082426110007, 082426110008, 082426110009, 082426110010, 082426120006, 082426120007, 082426120011, 082426120013, 082426120015, 082426120016, 082426120017, 082426120018, 082426120019, 082426120020, 082426120021, 082426120022, 082426130020, 082426130021, 082426130023, 082426130024, 082426130025, 082426130026, 082426130027, 082426130031, 082426130032, 082426130033, 082426130034, 082426130035, 082426130037, 082426130038, 082426130039, 082426140016, 082426140017, 082426140018, 082426140019, 082426140020, 082426140021, 082426140022, 082426140023, 082426140024, 082426150012, 082426150013, 082426150014, 082426150015, 082426150016, 082426150018, 082426150019, 082426150021, 082426150022, 082426150023, 082426150024, 082426150025, 082426150029, 082426150030, 082426150031, 082426160025, 082426160026, 082426160027, 082426160030, 082426160031, 082426160032, 082426160033, 082426160034, 082426160035, 082426160036, 082426160038, 082426160039, 082426160040, 082426170003, 082426180007, 082426180009, 082426180010, 082426180011, 082426180013, 082426190014, 082426190015, 082426190016, 082426190017, 082426190020, 082426200003, 082426200004, 082426200007, 082426200008, 082426200009, 082426210013, 082426210015, 082426210016, 082426210017, 082426210019, 082426220007, 082426230015, 082426230016, 082426230017, 082426230018, 082426240003, 082426250003, 082426270005, 082426270006, 082426270007, 082426270008, 082426290005, 082426290006, 082426290008, 082426310015, 082426310016, 082426310019, 082426310021, 082426310022, 082426310024, 082426310025, 082427140029, 083026002000469, 083026002000938, 083026002002289, 083026002100219, 083026002100286, 083026002101088, 083026003811611, 083026006866397, 083026008153639, 083026022002291, 083026022002299, 083026026463911, 083026062000397, 083026062102318, 083026102101827, 083026202100317, 083026202100886, 083026202100929, 083026202101361, 083026202102248, 083026202592007, 083026206522477, 083026242101977, 083026600020711, 083026602100924, 083026602100925, 083026602101279, 083026602101643, 083026602101669, 083026602634522, 083026608462741, 083026801003210, 083026802100537, 083026802101686, 083026805120043, 083026822100376, 083026822100655, 083026822100665, 083026822101249, 083026842101377, 083026842101817, 083026861008410, 083026862100378, 083026862100513, 083026862100874, 083026862101014, 083026867892981, 083026867892988, 00002NUC02, 00013NUC01, 00018NUC04, 00034NUC01, 00053NUC06, 00053NUC09, 00065NUC05, 00067NUC01, 00100NUC02, 00105NUC03, 00109NUC01, 00109NUC04, 00116NUC01, 00130NUC03, 00130NUC04, 00131NUC03, 00133NUC21, 00136NUC03, 00136NUC08, 00141NUC06, 00165NUC04, 00169NUC07, 00171NUC04, 00186NUC02, 00187NUC01, 00197NUC11, 00203NUC03, 00216NUC11, 00231NUC09, 00234NUC05, 00240NUC05, 00253NUC02, 00257NUC06, 00257NUC15, 00260NUC03, 00263NUC08, 00271NUC04, 00289NUC02, 00311NUC01, 00313NUC01, 00318NUC03, 00318NUC10, 00331NUC02, 00348NUC02, 00361NUC05, 00371NUC04, 00373NUC01, 00374NUC05, 00379NUC01, 00383NUC03, 00393NUC06, 00433NUC09, 00439NUC08, 00440NUC07, 00440NUC09, 00440NUC11, 00487NUC04, 00669NUC01, 01002NUC04, 010120NU11, 01012NUC01, 01042NUC01, 01243NUC02, 01344NUC01, 01367NUC01, 030010NU05, 030018NU05, 030037NU04, 030057NU05, 030078NU13, 030151NU12, 030209NU02, 030232NU10, 030232NU13, 030240NU07, 030388NU04, 030419NU09, 05217NUC05, 05452NUC03, 06008NUC09, 06014NUC02, 06051NUC01, 06051NUC04, 06109NUC01, 06109NUC02, 07015NUC01, 080004NU11, 080004NU13, 080026NU08, 080053NU02, 100029NU01, 10181NUC06, 10448NUC04, 10497NUC01, 10497NUC03, 10627NUC01, 110009NU01, 110022NU03, 110034NU04, 110064NU01, 110093NU07, 11018NUC04, 130083NU13, 130139NU02, 150017NU05, 1577INFINIA, 160150NU04, 17005NUC01, 18076INFINIA, 190052NU06, 190057NU05, 190057NU10, 190073NU01, 190171NU05, 190187NU01, 190194NU01, 190205NU06, 190282NU09, 202715INF4, 203325INF, 203325INF2, 203384INF, 203688INF, 203797INF, 203852INF, 204787INFINIA, 204787INFINIA2, 204837HK1, 204837IN1, 205408INF2, 205750INF, 205759INF, 205783INF1, 205939INF, 206223INF, 206223INF2, 207255INFINIA, 207795INFINIA, 208422INF, 209223IN, 209385IN, 209526IN, 209831IN, 210036NU06, 21011NUC01, 210358IHE, 210575INF1, 210617NM1, 210705NM1, 210757NM1, 210921NM1, 210MTINFINIA, 212241INF1, 212241INF2, 212241INF3, 212562INF1, 212608INF1, 212686INF1, 212989INF1, 214324INF, 214370INF, 214820INF1, 214820INF2, 214879INF, 215427INFINIA, 215537INFINIA, 215707INFINIA, 215710INFINIA, 215728INFINIAJ, 215952INF, 215952INF2, 217223INF1, 217223INF2, 217347INF2, 217347INFINIA, 217528NUC, 217544NUC1, 217554CINF, 218847INF, 220826NU01, 225381INF, 225647INF, 225658INF, 225765INF1, 225INFINIA, 225NOINF, 228436INF, 228523HWK, 228523HWK2, 228818INF, 228865HWK, 229259INF, 229333ICINF1, 229333ICINF2, 229SUMINF, 23002NUC01, 23003NUC01, 231935INF, 239NCHINF1, 240566INF, 248465INF, 248471INF, 248849INF1, 248849INF2, 248898INF, 248898INF2, 250339INFINIA4H, 250370INFINIAH4, 250565NUC4, 250727INFINIA1, 250754INFINIA, 250754INFINIA2, 250785INF1, 252436INF1, 2543334INFINIA, 254519NMINF, 254743NM, 254743NM2, 256327NUC, 256341NRM1, 256386HKNM2, 256429INF1, 256494NM1, 2565059INFINIA, 256543INF1, 256761INF, 2583615INF, 2585033INF, 259170NU02, 260010NU05, 2605823INF, 2612588INF2H, 262010NU01, 262329INF, 262334INF, 262363INF, 262434INF1, 262434INF2, 262569INF, 262574INFIN, 262574INFIN3, 262656INF1, 262656INF2, 262670INF2, 262687INF, 262687INF2, 262741INF, 262741INF2, 262767INF, 262948INF, 26329NM1, 2633201INF, 2646005INF, 2660585INF, 269223VABCINF, 2694427INF, 269657SHINF, 270651INF1, 270688INF, 2721482INF, 2723INFINIA, 2750751INF, 2766055INFHE4, 281251SLVINF, 281274DINF, 281274INF, 281338INF1, 281348INF, 281420INF, 281599INF1, 281637INF, 281897INF1, 2864298INF, 2919654INF, 2928217INF, 2954INFINIA, 2962725INFINIA, 300013NU01, 301295INF1, 301295INF2, 301714INF, 301877INF, 302428INF, 302629INF, 302733INF, 302744INF1, 303320IH, 303399IH, 303450INF, 303837INF, 303839INF, 304264INF, 304623INF1, 304623INF2, 304637INF, 304831LNM1, 305227INF1, 305227INF2, 305325INF, 305575INF1, 305575INF2, 305682INF1, 305835INF, 305VAMIAMI, 306655INFINIA, 306655INFINIA2, 306655INFINIA3, 306655INFINIA4, 306655INFINIA5, 306766INF1, 306766INF2, 307332INFINIA, 309344SMNUC, 309655INF1, 309779INF, 310319INF1, 310543INF1, 310832INF1, 312996INF, 313343INF1, 313343INF2, 313343INF3, 313343INF4, 313473INF, 314525INF1, 314525INF2, 315425INF, 316268VCFI, 316268VCFI2, 316858GI, 316962WI, 317338HAWK, 317415INF, 318327INF1, 318330INF1, 318388INF1, 318681INFINIA, 318681INFINIA2, 318798INFINIA, 319272INF, 319356INF, 319768INF, 319768INF2, 323268INF1, 325235NUC, 330343INFINIA, 330344INFINIA1, 330363INFINIA1, 330363INFINIA2, 330363INFINIA3, 330721INFINIA1, 330721INFINIA2, 337289INF, 337436INF, 337981INF, 34006NUC03, 34017NUC01, 34017NUC02, 34021NUC02, 34094NUC02, 34284NUC04, 34318NUC01, 34329NUC01, 34335NUC01, 34340NUC01, 34351NUC01, 35003NUC04, 35003NUC05, 352333INF, 352344INF, 352596INF1, 360PSPHINF1, 361572NM1, 361595SKI1, 361694DNMINF, 361881SSINF1, 361985SNM, 36INF2753220, 38001NUC01, 38001NUC02, 386326INF1, 386362INF1, 3882942310MNCTR, 401444INF, 402354HWK, 402354INF, 402449INF, 402461INF, 402559INF1, 402559INF2, 403229INFINIA, 403251INFINIA1, 403289NUC1, 403289NUC2, 403382INFINIA1, 403382INFINIA2, 403541INFINIA, 403670NUC8, 403777INFINIA, 403777INFINIA2, 403777INFINIA3, 404265INF, 404321INF, 404466INF, 404605INF, 404686INF, 404712INF, 405271IH1, 405271VAINF1, 405307INF1, 405610MINF1, 405742INF1, 406228FINF, 406238INF, 406731INF1, 408259IN1, 4082IN, 408315IN, 408315IN2, 408559IN1, 408851IN, 409727NM1, 409938INF, 409985NMI1, 41009NUC01, 410337INF, 410337INF2, 410337INF3, 410550INF, 410605INF, 410822HK1, 410955INF, 412343INF1, 412372INF1, 412653INF1, 412692INF1, 412692INF2, 414325INF, 414384INF, 414489INF, 414649INF, 414805QUA, 414ISCINFIN2, 414ISCINFINIA, 415222IN1, 415300IN, 415353IN, 415353IN2, 415677INF, 415750IN1, 415838IN, 415925INF, 416444INFINIA1, 416469INHE4A, 416469INHE4B, 416633INFINIA, 416756INFINIA, 416756INFINIA2, 416813INFINIA, 416864INFINIA1, 416864INFINIA2, 416928INFINIA, 417256INF, 418275INFINIA, 418589INFINIA, 418649NUC1, 419227I1, 419227I2, 419238INF, 419383NM1, 419423NUC, 419455INF1, 419483NUC2, 419933I1, 423472INF, 423493PINF, 423553INF, 423625INFINIA, 423778EDINF, 423778MMINF, 425261INF, 427459NU02, 432685DNUC, 434924INF1, 434924INF2, 434924INF3, 435251INF1, 435251INF2, 435658INF, 435750INF2, 435781INF1, 435893INF, 44014NUC01, 441236INFINIA, 443481BINF, 443481INF, 443481INF2, 45001NUC01, 45011NUC01, 450468INFINIA, 450654INF1, 450654INF2, 450654INF3, 450746INFINIA, 469764INF, 4716INFINIAHE4, 475290NU01, 478272INF, 478454INF, 478633INFINIA, 478633INFINIA2, 479441INF1, 479463INF, 479463INF2, 479549INF, 479553INF, 479751INF, 479967INF, 480301NM1, 480323INFRM1, 480323INFRM2, 480323INFRM3, 480324INF, 480512INF1, 480512INF2, 480882INF1, 480882INF2, 484503INFINIA1, 485520NU01, 485520NU07, 493519NU01, 493519NU02, 501202INF, 501620INF, 501776INF, 502259INF, 502287INF, 502350INF, 502624INF, 502868INF1, 502893INF, 502955INF, 503435INF, 503561HK4, 503561INF, 504380INF, 504454INF, 504537INF, 504826INF, 504838INFH, 504873INF, 504873INF2, 505262INF, 505609INFINIA, 505863INF, 506544NUCGE, 506739INFINIA, 506739INFINIA2, 507345INF1, 507402INF1, 507434INF1, 507457INF1, 507OLMINF1, 508427INF2, 508427INFINIA, 508457INF, 508674INFINIA, 508828INF, 509473INFINIA, 509474INFINIA, 509946INF, 510400IN, 510437IN, 510537IN1, 512324NM, 512397INF, 512528NM1, 512LRMCNM, 513298INF1, 513298INF2, 513454INF1, 513585INF, 513636INF, 513867INF, 514252AINFINIA1, 514252AINFINIA2, 514252AINFINIA4, 514252AINFINIA6, 514340INFINIA, 514371INFINIA, 514495INFINIA, 514842AINFINIA, 514842AINFINIA2, 514934AINFINIA, 515247INF1, 515247INF2, 516562INFINIA1, 516562INFINIA2, 516570INF, 516622INFINIA, 516IPKINF1, 517543INF, 518262INF1, 518262INF2, 518262INF3, 518271INF, 518562INF, 518626INF, 518773INF, 518828INF, 518926INF, 519631INFINIA, 519663INFINIA2, 519685INFH4, 519685INFINIA, 519685INFINIA2, 519749INFINIA, 519749INFINIA2, 519752INFINIA, 519752INFINIAH4, 519965INFINIA, 52006NUC01, 520868INF, 520VAINF1, 529150NU03, 529150NU04, 530225IN, 530533IN, 530876IN, 540213INF1, 540332INF1, 540332INF2, 540332INF3, 540498INF1, 540536INF1, 540536OCHAWK, 540689INF1, 540689INF2, 540741HAWK1, 540741INF1, 541296HK4, 541387INF, 541440INF, 541754HK4, 559225IN, 559353IN, 561650INF1, 561744INF, 561744INF2, 562826INFINIA, 570398INF, 570501INF, 570552INF, 570621INF, 570621INF2, 570836INFINIA, 571231HAWK1, 571231INF1, 571231INF2, 573686INF1, 573686INF2, 580249IN1, 580931INF1, 585922INF1, 586226INF, 586416INF, 600042NM05, 600042NM06, 600044NM07, 600055NM04, 600092NM10, 600131NM05, 601288INF1, 601376INF1, 601443INF1, 601936INF1, 601978INF, 602239INF1, 602344NM1, 602406INF, 602406INF1, 602406INF3, 602406OPINF, 602588INF, 603650INFINIA1, 603924INF, 604228INFINIA1, 604278INFINIA1, 604278INFINIA2, 604434INFINIA, 604520INFINIA1, 604520INFINIA2, 604520INFINIA3H, 604520INFINIA4H, 604531INFINIAH, 604557INFINIAH1, 604557INFINIAH2, 604557INFINIAH3, 604588INFINIA1, 604588INFINIA2, 604588INFINIA3H, 604588INFINIA4H, 604875INFINIA1, 604875INFINIA2H, 605333INF2, 605333INF3, 605333INF4, 605333INF5, 605333INFINIA, 605353NM, 606878INF1, 606878INF2, 607274INF, 607274INF2, 607737INF, 607756INF, 607756INF2, 607762INF, 607763INF, 608263INF, 608263INF2, 608263INF3, 608324INF, 608756INF, 608775INF1, 608775INF2, 608775INF3, 608791INF, 609267INF, 609652INF, 609730INF1, 609730INF2, 609835INFINIA, 610278INFINIA, 610327INFINIA, 610402INFINIA, 610402INFINIA2, 610437INFINIA, 610770INFINIA, 610869INF, 610954INFINIA, 613727INFIN, 613761INFINIA, 613969HAWKEYE, 613969INFINIA, 614478INF1, 615284INF1, 615322NM3, 615327VANM1, 615328NM1, 615342INF1, 615349NM1, 615349NM2, 615768SCNM1, 615769NM1, 615781NM1, 615893NM1, 615896NM1, 616267INFINIA, 617243INFINIA, 617296INF, 617313INF1, 618234INF1, 618256INF1, 618395INF, 618544INF, 618942INF, 618993INF, 619229INF, 619482INFINIA, 620225WPI, 620232INF, 623207INF, 623478NM2, 623848NM2, 623882INF, 626359INF1, 626359INF2, 626570INF1, 626573INF1, 626898INF1, 626915INF1, 63009NUC01, 630275INF, 630275INF2, 630312INF, 630545INF, 630786INF, 630801INF, 630856INF, 6502IN1, 6502IN2, 650367IN1, 650725IN, 650725IN2, 650858IN1, 650858IN2, 650858IN3, 651241INF1, 6525011INF1, 661633NM1, 661949NUC1, 661PMCNUC1, 662244INFINIA, 662256INFINIA, 662377INFINIA, 662423INFINIA, 662608NU01, 662772INFRM1, 662772INFRM2, 662772INFRM4, 671USNHINF, 678474INF, 681342INF1, 681342INF2, 681342INF3, 681342INF4, 70027NUC03, 70060NUC12, 701234INF, 701234INF2, 701364INF, 701774NM, 701857NM, 701952NM, 702255INF, 702360CHNM, 702369NM, 702388VNM, 702853NM, 703391INF1, 703391INF2, 703504HAWK1, 703558INF, 703689INF4, 703698INF1, 703858HAWK, 703858INF, 704225INF1, 704225INF2, 704304INF1, 704304INF2, 704316INFI, 704355INF1, 704355INF2, 704384HAWK1, 704384INFI2, 704384INFI4, 704384INFI5, 704384INH1, 704446INF1, 704487INFINIA1, 704660HAWK, 704667INF1, 704739INFI, 704783INFI1, 704783INFI2, 704783INFI3, 704863INF1, 705674HAWKEYE, 705674INFINIA, 705759HAWKEYE, 705759INFINIA2, 706278INF, 706291HINM, 706494HNM, 706651INF, 706651NUC, 706733INF, 707822INFINIA, 707963IN, 708660INF, 708684INF1, 708747INFACQ, 709637INFINIA1, 709651INFINIA, 709651INHE4A, 709737INFINIA, 709737INFINIA2, 709737INFINIA3, 712279INF, 713242INF1, 713242INF2, 713242INF3, 713359INF1, 713456INF, 713722INF, 713785SLINF1, 713785SLINF2, 713785SLINF3, 713794INF, 713794INF2, 713794INF3, 713ACCINF1, 714456INFINIA, 714953INFINIA, 715423INF, 715623INF, 715839INF, 716366INF, 717544INFINIA, 717627INFINIA, 717633INF1, 717633INF2, 717782INF, 718150INF1, 718240INF1, 718240INF2, 718250INF1, 718334INF1, 718334INF2, 718405INF1, 718518INF1, 718584INFINIA, 718616INF, 718630INF1, 718883INF1, 718883INF2, 718948INF, 718963INF1WH, 719333IH, 722050NU01, 724226INF1, 724357INF1, 724450INFINIA, 727461VG, 727521INF, 727581INF, 727843INF1, 727863INF1, 727893INF, 727942INF, 731425INFH1, 731425NMIC1, 731425NMRM, 731644INF, 732292INFINIA, 732321IH4, 732321INFINIA, 732530INFINIA, 732530INFINIA2, 732776INFH4, 732840INFINIA, 732923INFINIA, 732937INFINIA, 734246INF, 734467INF, 734475INF, 734671INF, 740264INF3, 740264INF4, 740356INF1, 740356INF2, 740383INF1, 740623INFINIA, 740922INFINIA, 740944NU01, 757259INF1, 757312INF1, 757312INF2, 757388INF2, 757395INF1, 757398INF1, 757398INF2, 757668INF1, 757722INF1, 757886INF1, 757889INF1, 760241INF1, 760452INF1, 760778INF1, 760873NUC, 763MRCYINFI, 763UNTYINFI, 765456INF, 765552INF, 770219INF, 770229INF, 770382INM, 770400INF, 770535INF1, 770751INF, 77137NUC01, 77139NUC05, 77187NUC01, 77260NUC03, 772LMCNM2, 773665INF1, 773665INF2, 77383NUC03, 773884INF, 773947INF, 773995INF, 774442INF, 775423INF1, 77624NUC01, 77624NUC03, 780489INFINIAH4, 780489INHE4B, 780489INHE4C, 780715INHE4A, 780875INFINIA, 781340INF, 781340INF2, 781340INF3, 781477INF, 781979INF1, 783348NU01, 785462CI, 786308INF1, 786308INF2, 787653INFINIA2, 787758INFINIA2, 787764INFINIA-1, 787848INFINIA, 78NMIH2564713, 801268INF1, 801299INF1, 801314INF1, 801357INF1, 801357INF2, 801387INF1, 801408INF, 801408INF2, 801465INF1, 801479INF, 801479INF2, 801501INF1, 801584INF1, 801584INF2, 801584INF3, 801588INF, 801ALTAINF2, 801IMCCARD, 801IMCINF, 801IMCINF1, 801RHINF, 801SLCINF, 802257INF, 802388INF, 802775INFINIA, 803329HAWK, 803329INFIN1, 804225INF1, 804254INF, 804281INF1, 804323INF1, 804594INF1, 804675INF1, 804957INF1, 804957INF2, 805370INF1, 805489INF1, 805543INF1, 805737INF1, 806354ACINFINIA, 806354NWINF, 806354NWINF2, 806GRACENM, 809758INFINIA, 812265KDINF, 812426INF, 812485INF, 812522INF, 812842INF1, 813788INF1, 813870INF, 813USFINF1, 814333INFINIA1, 814333INFINIA2, 814362INFINIA, 814452INF1, 814467INF, 814533INF, 814534INF1, 814643INF, 814723INF, 814877INFINIA, 814889INFINIA, 815395INF, 815432INF, 815432INFINIA, 815741INF1, 815741INF2, 815756INF, 816271SJINF, 816348INF1, 816380CASSINF, 816392RINF, 816404INF1, 816836CIIN, 817255INF, 817346INF, 817472INF, 817599INF, 817685INF, 817920INF, 818409INF2, 818884INF1, 818907INF1, 819357BINFINIA, 819378INFINIA, 819537INFINIA, 819537INFINIA2, 819563CINFINIA, 819595INFINIA, 828262INFINIA, 828286INFINIA, 828298HAWK1, 828298HAWK2, 828315HWK4, 828586INFINIA, 828696INFINIA1, 828766INFINIA, 828883INFINIA, 831755IN1, 832505NM1, 832522INF, 832522INF2, 832824INF, 843402INF, 843402INF2, 843412INF, 843431IN, 843606INF1, 843674IN1, 843674IN2, 843674IN3, 843689INF, 843692IN1, 843724INF, 843724INF2, 843777IN1, 843777IN2, 843777IN3, 843782INF, 843797INF1, 843832INF, 845794INFINIA, 845987INFINIA, 847480INF, 847535INFACQ, 847990INF1, 849010NU01, 850494HAWK, 850883ENM, 856247INF, 856363INFINIA, 858554EDCINF, 858554INF1, 858554INF2, 859268INF1, 859313INF, 859498INF1, 860344INF, 860350INIF, 863679INF1, 863680INF1, 863687INF1, 863687INF2, 864560HAWK1, 864675HAWK, 864675INFI, 864SPAHK1, 864SPAHK2, 865271NM1, 865373INF, 865429INFINIA, 865545INFINIA1, 865717INF, 865947INFINIA1, 865977INF, 876259NU01, 885INFI1, 885INFI2, 900010NU06, 901287INF1, 901495INFHAWK, 901495INFINIA, 901516NINFHK, 901516UINFHK, 901523INF1, 901523INF2, 901765INFRM8, 902567NUCINH4, 903416INF, 903731INFINIA, 903785INF, 903UTINF, 904202INF1, 904276INF1, 904321INF1, 904542NM, 904627INF1, 904627INF2, 904819INF1, 904821INF3, 904821NM1, 904821NM2, 905358INFINIA, 905372INFINIA, 905472INFINIA, 905472INHE4A, 905521INFHE4, 905522INFINIA, 905522INFINIA2, 905577INFHE4A, 905577INFHE4B, 905683IN1, 905731INFINIA, 905773INFINIA1, 905813INFINIA, 905813INFINIA2, 905832INFINIA, 905845INFINIA1, 905848INFINIA, 905855INFINIA, 905855INFINIA2, 905855INFINIA3, 905883HAWKEYE, 905895INFINIA1, 905895INFINIA2, 906293INF, 906774INF, 906776INF, 907562NM1, 907562NM2, 908522INFINIA, 908522INFINIA2, 908522INFINIA3, 909825INFINIA, 910323INF1, 912486EGNC, 912691SCNC, 913345INF1, 913541INF1, 913588INF, 913588INF1, 913588INF2, 913676SMIM, 915521HNM1, 915577NM1, 915595GNM1, 916453IN, 916537IN, 916537IN2, 916703IN1, 916703IN2, 916733IN, 916781IN, 916782IN1, 916782IN2, 916983INFN1, 918294INF1, 918307INF1, 918307INF2, 918376INF1, 918494INF1, 918494INF2, 918494INF3, 918502INF1, 918599INF1, 919684INF1, 919684INF2, 919684INF3, 919784INF1, 919934INF, 920288INF, 920288INF2, 920451INF, 920456INF, 920568INF, 920684INF, 920729INF, 920738INF, 920738INF1, 920738INF2, 920794INF, 920849INF, 920907INF, 925370IN, 925779IN, 925785IN, 925INF, 928214INF, 928442INF, 928537INF, 928855INF, 931381NM2, 931403NM1, 931967NM, 937208INF1, 937208INF2, 937268INF1, 937278INF, 937328INF1, 937328INF2, 937374INF1, 937386INF, 937390INF1, 937393INF, 937438INF, 937440INF1, 937440INF2, 937832INF1, 941235INF, 941629INF, 941637INF, 941766INF2, 941VRMCINF, 951672INF1, 951696INF1, 954265INF1, 954735INF1, 954735INF2, 954978INF1, 956350NM1, 956687INF2, 956971NM1, 970350IH, 970945INF, 972394INF, 972498INF, 972540INF, 972596INF, 972969INF, 973579INFINIA, 973625INFINIA, 973676INFINIA, 973831INFINIA, 973877INFINIA, 973971INFINIA, 978521INF, 979241INF, 979532INF1, 980212INF1, 985230INF, 985646INF, 985649INF1, 985649INF2, 985785INF, 989723INF1, 989723INF2, A004NU11, A186363001, A4169304, A4194407, A51043155, A51043187, A5107756, A5107766, A5109126, A5109665, A5109666, A5111127, A5111240, A5112411, A5113627, A5114292, A51149103, A5115111, A51152163, A51152164, A5118056, A5118088, A5120724, A5123523, A5124139, A5127292, A5128755, A5128757, A5129026, A5129959, A5152964, A5153612, A5162248, A5172907, A5172908, A5178021, A5181660, A5181662, A5189714, A5197927, A5197934, A5198016, A5215935, A5216823, A5216824, A5224207, A5267107, A5279301, A5279302, A5306502, A5315551, A5352208, A5367805, A5547414, A5634003, A5649008, A5719812, A58080111, A58080134, A5924402, A99263311, AC001NU14, AC001NU18, AF1026NM01, AH1908NU01, AH1908NU02, AH3403NU01, AH3701NM05, AH4307NM05, AH4660NM06, AH5117NU02, AH5249NM04, AH5293NM04, AH5689NU01, AH5689NU03, AH5689NU04, AH5844NM05, ALM0131, AMS0338, APL0232, ARHINFI, B1650218, B1768001, B4155415, B4182004, B5119121, B5142302, B5142304, B5174320, B5315345, B5357630, B5365422, B5395703, B5483443, B5618331, BCHINF1, BRMCINF, C001NU06, C001NU10, C4191749, C4191765, C5120912, C5120915, CC3899NU01, CE561221, CFRHINF, CHAM01NU01, COR359309, COR369576, COR373273, COR373282, CRAVENINF1, CRAVENINF2, CRAVENINF3, CS1008NM03, CS1021NM03, CS1052NM08, CS1052NM09, CS1277NM01, CS1277NM02, CS1318NM01, CSNMINFINIA, CY1015NM01, D5111602, D5111607, DE492A51, DE528467, DE539254, DE6588112, DEH13556, DEN01721, DEN01723, DEN01725, DEN01727, DHG0539, DK1022NM05, DK1023NM03, DK1023NM05, DK1026NM07, DK1026NM08, DK1029NM05, DK1065NM04, DK1065NM05, DPN00002, DVT0138, DZ1035NM03, DZ1035NM04, DZ1147NM01, DZ1279NM01, DZ1338NM01, E001NU16, E4858901, EE1019NM02, EE238526, EEF51540, EG1100MN01, EG1124MN02, EG1538MN01, EG1826MN01, EMM0131, F5119151, FE443890, FEB33835, FEE12426, FEG46134, FHEINF, FI1000MN04, FI1003MN05, FI1003MN06, FI1010NM01, FI1019MN01, FI1021MN01, FI1023MN02, FI1029MN01, FI1064MN01, FI1153MN01, FPG86405, G4191710, GE1004NM01, GILESINF, GOLD001642, GOLD010343, GOU0137, GOU0138, GPQ19105, H002NU01, H010NU04, H010NU08, H2094NUC07, H2094NUC28, H2100NUC02, H2193NUC13, H4858974, HC0074NU01, HC0507NU03, HC0842NU01, HC0863NU01, HC0892NU04, HC1249NU01, HC1249NU02, HC1819NU01, HC2252NU01, HC2720NU02, HC3442NU01, HC4387NU02, HC4480NU01, HC7475NU03, HDB0130, HGL0233, HGV0130, HLUE01NU01, HLV0334, HR4103NM01, HU1039NM02, HU1099NM01, IE1006MN04, IE1029MN04, IE1029MN05, IE1053MN01, IE1085MN05, IE1100MN01, IE1110MN01, IE1510MN09, IE1510MN12, IE1510MN16, IE1564NM01, IE1564NM03, IL1018NM07, IL1018NM08, IL1020NM25, IL1020NM31, IL1028NM26, IL1041NM18, IL1041NM22, IL1041NM28, IL1041NM29, IL1042NM09, IL1043NM20, IL1059NM07, IL1062NM26, IL1068NM05, IL1069NM06, IL1069NM11, IL1331NM01, INF2649553, IR1049NM01, IR1501NM01, JO1034NM01, JOHNINF, KW1001MN23, KW1001MN25, KW1005MN11, KW1005MN14, KW1006NM01, KW1013NM01, KW1013NM02, KW1018MN05, KW1018MN06, KW1018MN08, LB1122NM02, LDD0431, LDD0433, LGMCINF, LGMCINF2, LT4000MN01, LT4000MN02, LV4002NM02, M1106608, M1279727, M1400803, M1804913, M1804914, M204493801, M2147255, M218669001, M2269829, M23084315, M256517203, M2645705, M2846905, M4018099, M4018536, M4023087, M4024095, M40345193, M4040544, M4111216, M4135141, M4135145, M4143953, M4144332, M4144340, M4145143, M4159227, M4159228, M4159235, M4159460, M4160449, M4163763, M4167153, M4184856, M4191430, M4194031, M4198189, M4215553, M4234232, M4234235, M4479619, M4480229, M4480232, M44827146, M4496943, M5172527, M54606103, M7411101, M7411106, M8572211, M9162716, M9164758, M9319116, M9886832, MA1020NM01, MA1272NM01, MA1439NM01, ME051533, ME208350, ME244391, ME244393, MEX68919, MPP0131, MPX46902, MPX47106, MPX52309, MPX82204, MPX99201, MQ1000MN04, MT1014NM01, MT1014NM02, MVINFNM2, N001NU02, N001NU06, NA1027NM01, NASHNM2, NE209938, NM156449, NM18342, NM18346, NM18356, NM18357, NM18363, NM18365, NM18409, NM18444, NM18451, NM18471, NMCR-17849, NMCR-17980, NMINDTCRL0206, NMINDTCRL0227, NMINDTCRL0311, NMINDTCRL0351, NO1000MN03, NO1000MN06, NO1016MN16, NO1054MN01, NO1068MN07, NO1068MN09, NO1070MN07, NO1088MN09, NO1116MN09, NP739716, NPV15964, NUC5178133HM6, O005NU14, OBNM1, ORMCINFINIA1, ORMCINFINIA2, P4211482, PC1268NU03, PC1818NU03, PC3906NU02, PC3964NU02, PC3970NU02, PC5995NU01, PC8118NU01, PER03520, PER08009, PITTINF4, PITTINF5, PK1001NM01, PK1031NM01, PK1032NM01, PK1180NM03, PK1180NM08, PK1184NM01, PK1278NM01, PK1307NM01, PK1335NM01, PK1336NM01, PK1355NM01, PL1003NM03, PL1143NM03, PL1143NM06, PL1692NM01, PM1633NU03, PMR12506, PPR08202, PPR12213, PPR59030, PPR97306, PPS06907, PRINCEINF, R4211480, RO1224NM01, RU1018NM01, RU1021NM02, RU1085NM02, RU1091NM01, RU1095NM02, RU1152NM02, RU1212NM01, RU1284NM01, RU1294NM01, RU1302NM01, RU2050NM01, RU2199NM01, RU2311NM01, RU2311NM02, RU2526NM01, RU2527NM02, RU2527NM03, RU3143NM02, RU3314NM01, RU3424NM01, RU3448NM01, RU3508NM01, S4160059, S4160079, SA1001MN01, SA2146NM01, SLGHINF, TN1366NM01, UC4109NU02, UC7655NU03, UC7655NU04, UE282633, UE282648, UE720407, UEW19003, UEW19005, UK1110NM01, UK5002NM01, UP285A41, UPW00402, V1471114, V2147210, V2728105, V2728109, V2943412, V2943415, V4198004, V6414104, V7405209, V7406615, V7406617, V8572204, VASINF, VCWESTINF, VVMCINF1, X100611101, X105967809, X105967813, X119197203, X151957601, X2034002, X4211026, X59007307, X61014001, Y004NU08, Y004NU11, YE364413, YE364417, YE626937, YN1196, YN1200, YN1539, YN1540, YN1541, YN1542, YN1543, YN1544, YN1545, YN1546, YN1547, YN1548, YN1549, YN1550, YN1551, YN1552, YN1553, YN1554, YN1555, YN1556, YN1557, YN1558, YN1559, YN1560, YN1561, YN1562, YN1563, YN1564, YN1565, YN1566, YN1567, YN1568, YN1569, YN1570, YN1571, YN1572, YN1573, YN1574, YN1575, YN1577, YN1578, YN1579, YN1580, YN1581, YN1582, YN1583, YN1584, YN1585, YN1586, YN1587, YN1588, YN1589, YN1590, YN1591, YN1592, YN1593, YN1594, YN1595, YN1596, YN1597, YN1598, YN1599, YN1600, YN1601, YN1641, YN1650, YN1730, YN1742, YN1743, YN1744, YN1745, YN1760, YN1802, YN4218, YN4219, YN4220, YN4221, YN4222, YN4223, YN4224, YN4225, YN4226, YN4227, YN4228, YN4229, YN4230, YN4231, YN4232, YN4233, YN4234, YN4235, YN4236, YN4237, YN4238, YN4239, YN4240, YN4241, YN4242, YN4243, YN4244, YN4245, YN4248, YN4249, YN4250, YN4251, YN4252, YN4253, YN4254, YN4255, YN4256, YN4257, YN4258, YN4259, YN4260, YN4261, YN4262, YN4263, YN4264, YN4265, YN4266, YN4267, YN4270, YN4280, YN4288, YN4300, YN4312, YN4818, YN4819, YN4820, YN4821, YN4822, YN4824, YN4825, YN4830, YN4833, YN4900, YN4918, YN4919, YN4920, YN4921, YN4922, YN4923, YN4924, YN4925, YN4926, YN4927, YN4928, YN4929, YN4930, YN4931, YN4932, YN4933, YN4934, YN4935, YN4936, YN4937, YN4938, YN4939, YN4941, YN4942, YN4943, YN4944, YN4945, YN4946, YN4947, YN4948, YN4949, YN4950, YN4951, YN4952, YN4953, YN4954, YN4955, YN4990, YN4992, YN4999, YN5000, YN8001, YN8002, YN8003, Z001NU06, ZA1806NM12, ZA1807NM11, ZA1808NM13, ZA1820NM04, ZA1835NM24, ZA1835NM25, ZA2006NM04, ZA2008NM04, ZA2212NM02, ZA2246NM01, ZA2261NM01, ZTP0133, ZWL0437.
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact technical services
Manufacturer Reason
for Recall
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
FDA Determined
Cause 2
DESIGN: Device Design
Action GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
Quantity in Commerce 2474
Distribution Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
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 = KPS and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA