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

Class 2 Device Recall

  • 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
see related information
Date Posted April 10, 2013
Recall Status1 Terminated on January 27, 2014
Recall Number Z-1078-2013
Recall Event ID 64398
Premarket Notification
510(K) Numbers
K022960  K052434  K991841 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Code Information System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1 501202INF 662244INFINIA 225381INF 972394INF 727863INF1 713359INF1 419483NUC2 406731INF1 228436INF 865977INF 804281INF1 804225INF1 941VRMCINF 248471INF 203384INF 269657SHINF 718240INF2 718240INF1 BCHINF1 513454INF1 843402INF2 843606INF1 609730INF1 GILESINF 217554CINF 843674IN1 843674IN2 843674IN3 704225INF1 704355INF1 704355INF2 704863INF1 770382INM 973877INFINIA 859313INF 423625INFINIA 859498INF1 937440INF2 606878INF1 606878INF2 512528NM1 305325INF 615342INF1 816380CASSINF 816392RINF 816836CIIN SLGHINF 207795INFINIA 518562INF 757312INF1 757312INF2 410337INF3 973831INFINIA 708684INF1 302733INF 318681INFINIA2 281599INF1 805489INF1 352344INF 256327NUC 704487INFINIA1 718948INF 843782INF 931403NM1 256429INF1 CFRHINF 727521INF 904276INF1 702255INF 210617NM1 847990INF1 814533INF2 814534INF 607756INF 607756INF2 740623INFINIA 319272INF CRAVENINF2 CRAVENINF3 CRAVENINF1 618544INF 402449INF 337436INF 318798INFINIA 203797INF 304637INF 205750INF 205759INF 256341NRM1 760778INF1 702369NM 760241INF1 850883ENM 904542NM 502624INF 727581INF 630786INF 786308INF1 786308INF2 214324INF 919684INF3 318330INF1 843412INF 504454INF 303837INF 330721INFINIA1 330721INFINIA2 502350INF 904819INF1 928214INF FHEINF 954735INF2 813788INF1 225647INF 318327INF1 318388INF1 601288INF1 865373INF 865429INFINIA 240566INF 256494NM1 316858GI 662256INFINIA 561650INF1 843692IN1 319768INF 319768INF2 770229INF 979532INF1 706278INF 828586INFINIA 262670INF2 978521INF 517543INF 727942INF 256386HKNM2 906293INF 618942INF 305835INF 847480INF 843689INF 605353NM 435251INF1 801357INF1 701364INF 703858INF 815432INFINIA 814643INF 773947INF 570398INF 502955INF 859268INF1 502259INF 732321INFINIA 954265INF1 561744INF 305227INF1 305227INF2 262656INF2 513867INF 441236INFINIA 704739INFI 281348INF 307332INFINIA 225658INF 772LMCNM2 901287INF1 LGMCINF 304831LNM1 951672INF1 805737INF1 805370INF1 304623INF1 304623INF2 609835INFINIA 707822INFINIA 409938INF 828696INFINIA1 252436INF1 415925INF 925779IN 740383INF1 843431IN 402461INF 931381NM2 843777IN1 843777IN2 814333INFINIA1 814333INFINIA2 478633INFINIA 732840INFINIA 580931INF1 727843INF1 815756INF 609267INF 713242INF2 713242INF3 432685DNUC 812522INF MVINFNM2 913345INF1 209385IN 419455INF1 701774NM 281274INF 402354INF 832522INF 832522INF2 614478INF1 615349NM1 615349NM2 860344INF 662772INFRM1 662772INFRM2 662772INFRM4 405610MINF1 617313INF1 603924INF 973971INFINIA 212241INF2 801465INF1 302629INF NASHNM2 601443INF1 518773INF 239NCHINF1 281897INF1 212608INF1 COR373273 COR373282 617243INFINIA 405307INF1 352333INF 225NOINF 985230INF 770219INF 770535INF1 210757NM1 215537INFINIA 985646INF 479751INF 954978INF1 203852INF 704316INFI 516IPKINF1 352596INF1 708660INF 734467INF 734671INF 228818INF 885INFI1 885INFI2 478454INF 801479INF 801479INF2 ORMCINFINIA2 OBNM1 913541INF1 908522INFINIA2 908522INFINIA3 417256INF 661PMCNUC1 845987INFINIA 435658INF 423493PINF 803329INFIN1 PITTINF5 571231INF1 571231INF2 610327INFINIA 303839INF 815432INF 248849INF1 248849INF2 903785INF 505863INF 816348INF1 804254INF 618395INF 601936INF1 732530INFINIA 256543INF1 325235NUC 843402INF 843724INF2 773995INF 828286INFINIA 920849INF 918494INF2 918494INF3 918502INF1 501776INF 518271INF 310832INF1 502868INF1 480882INF2 435893INF 951696INF1 818907INF1 805543INF1 479524INF 605333INF2 985649INF1 985649INF2 856363INFINIA 404466INF 229259INF 229333ICINF1 229333ICINF2 912691SCNC 918294INF1 610869INF 615781NM1 301877INF 740356INF2 931967NM 804957INF1 804957INF2 616267INFINIA 540498INF1 828766INFINIA 504537INF 815395INF 309344SMNUC 217347INF2 217347INFINIA 985785INF 412343INF1 618234INF1 918307INF1 901765INFRM8 864675INFI 516562INFINIA2 309655INF1 708747INFACQ 225INFINIA 313343INF2 313343INF3 313343INF4 217544NUC1 773665INF1 773665INF2 765456INF 813870INF 410337INF2 602406INF 602406OPINF 281251SLVINF 713785SLINF2 610954INFINIA 281637INF 479967INF 580249IN1 409985NMI1 812485INF 214879INF 814452INF1 205408INF2 317415INF 912486EGNC 405742INF1 615328NM1 504380INF 504873INF2 404686INF 573686INF2 662423INFINIA 828883INFINIA 734475INF 903731INFINIA 918307INF2 570836INFINIA 310319INF1 806354NWINF 330343INFINIA 704225INF2 724450INFINIA 607762INF 681342INF1 681342INF2 681342INF3 681342INF4 434924INF1 434924INF2 434924INF3 913588INF1 774442INF 618256INF1 817472INF 208422INF 254743NM2 713794INF3 541440INF 269223VABCINF 906774INF 618993INF 757722INF1 509473INFINIA 702388VNM 910323INF1 970945INF 706733INF 478272INF 419238INF 210MTINFINIA 316268VCFI2 814723INF 479463INF 479463INF2 828262INFINIA 856247INF 623882INF 620225WPI 262687INF2 248898INF 248898INF2 757259INF1 814467INF 713722INF 817346INF 512324NM 210705NM1 765552INF 740264INF4 740264INF3 630275INF2 818884INF1 UK5002NM01 0853260023 0853260066 0853260074 0853260046 0853260056 0853260039 0853260087 0853260024 0853260045 0853260069 0853260042 0853260072 0853260062 0853260020 44014NUC01 06109NUC01 34318NUC01 01012NUC01 17005NUC01 21011NUC01 35003NUC04 23003NUC01 34284NUC04 45011NUC01 34335NUC01 23002NUC01 06008NUC09 06051NUC01 41009NUC01 52006NUC01 34017NUC01 07015NUC01 34094NUC02 63009NUC01 38001NUC01 38001NUC02 00013NUC01 01042NUC01 34021NUC02 34340NUC01 34351NUC01 0856260029 0856260031 0856260026 0856260028 0847260025 0002765581 A004NU11 Y004NU11 PPR12213 PPR59030 PMR12506 PPS06907 PK1001NM01 0843260034 0843260037 0843260044 2565059INFINIA NO1000MN06 HGV0130 GOU0137 GOU0138 HDB0130 MPP0131 MT1014NM01 MT1014NM02 MQ1000MN04 LT4000MN01 0850260077 0850260088 0850260089 0850260106 0850260107 0850260112 0850260079 0850260060 0850260061 0850260087 0850260076 0850260090 0850260105 0850260110 0850260068 0850260121 0850260065 0850260103 0850260081 0850260115 0850260123 0850260120 0850260093 0850260094 0850260063 0850260069 0850260070 0850260067 0850260073 0850260124 0850260091 0850260095 0850260104 0850260114 0850260083 0850260092 0850260113 0850260066 0850260080 0850260082 0850260099 0850260064 0850260100 YN1562 YN1566 YN1573 YN1581 YN1584 YN1571 YN1559 YN1579 YN1570 YN1551 YN1588 YN1575 YN1543 YN1586 YN4930 YN1567 YN1552 YN1561 YN8003 YN1560 YN1545 YN1554 YN4949 YN8001 YN1583 YN1556 YN1546 YN1558 YN1574 YN1544 YN1568 YN1569 YN1557 YN4922 YN1542 YN1563 YN4923 YN5000 YN1549 YN1564 YN1565 YN1547 YN4929 YN1541 YN1582 YN1540 YN1539 YN1550 YN4990 YN1577 YN1548 YN1587 YN1589 YN1578 YN1553 YN1196 YN1580 YN1555 YN1572 YN1585 YN4920 YN4918 YN4919 YN4924 YN4925 YN4927 YN4934 YN4921 YN4931 A5279302 A5181662 A5634003 B5142302 B5142304 A5315551 A5113627 A5178021 B5395703 C5120912 A5924402 A5109665 A5109666 A5216824 A5162248 A5352208 D5111607 A58080111 A58080134 A5111240 A5215935 A5129026 A5267107 A51043155 A51043187 A51152163 A51152164 B5365422 083026602101669 083026802101686 083026801003210 083026602101279 083026002002289 IL1069NM06 IL1068NM05 IL1018NM07 IE1006MN04 HU1099NM01 HR4103NM01 05452NUC03 00271NUC04 00624NUC01 00624NUC03 00116NUC01 00186NUC02 IE1564NM03 00289NUC02 00203NUC03 00231NUC09 00165NUC04 IE1510MN09 00669NUC01 00169NUC07 10497NUC01 00440NUC11 00440NUC07 70027NUC03 00171NUC04 77624NUC01 77624NUC03 V1471114 V2943415 V7406615 V7405209 M4159227 M4159228 M4018536 M4163763 M4018099 B5483443 A4169304 M8572211 M1400803 M4024095 A4194407 X105967813 M2269829 V2728105 M4167153 M218669001 M4211068 M5172527 X61014001 X100611101 M4023087 M9886832 M1279727 M4480232 M1804913 M4135141 B4182004 M4234232 M4234235 M4479619 M44827146 E4858901 M4144332 P4211482 R4211480 M9162716 X59007307 M7411106 X2034002 X151957601 S4160059 M4040544 M4215553 X4211026 FE443890 DE539254 UEW19003 UEW19005 MPX46902 DEN01721 DEN01727 UPW00402 GPQ19105 ME051533 UE720407 MPX82204 MPX47106 EG1826MN01 DK1023NM05 HC7475NU03 HC0842NU01 CHAM01NU01 UC7655NU03 HC0507NU03 HC1249NU01 HC1249NU02 493519NU01 PC1818NU03 PC8118NU01 HC1819NU01 CC3899NU01 HC3442NU01 HC0892NU04 HC4387NU02 2583615INF 2928217inf 262010NU01 475290NU01 529150NU04 905683IN1 613969INFINIA 819537INFINIA 819537INFINIA2 416928INFINIA 709737INFINIA 204837IN1 416813INFINIA 416444INFINIA1 905855INFINIA2 905855INFINIA3 905472INFINIA 905832INFINIA 613727INFIN 514934AINFINIA 416756INFINIA2 905773INFINIA1 905845INFINIA1 705759INFINIA2 403777INFINIA3 306655INFINIA2 306655INFINIA4 905895INFINIA1 905895INFINIA2 905522INFINIA 905522INFINIA2 705674INFINIA 519965INFINIA 905848INFINIA 250727INFINIA1 082426040034 082426040035 082426270006 082426190016 082426140020 082426140021 082426120006 082426120017 082426040037 082426110007 082426140017 082426150022 082426040033 082426070022 082426240003 2883051 NMINDTCRL0311 2827087 080004NU13 160150NU04 030018NU05 110093NU07 030010NU05 030037NU04 080053NU02 100029NU01 010120NU11 130083NU13 190073NU01 0910262234 0910262175 0910265053 0910265059 0910264085 0910264058 0910265055 0910264062 0910263190 0910264079 0910264129 0910262196 0910264152 AH5689NU01 AH3403NU01 ZA1820NM04 215952INF2 083026008153639 083026202100929 083026002000469 083026822101249 083026002100219 A5107766 DZ1338NM01 KW1005MN11 KW1018MN05 JO1034NM01 EG1100MN01 EG1538MN01 DZ1035NM03 DZ1035NM04 PK1180NM03 PK1335NM01 MA1272NM01 KW1005MN14 DZ1279NM01 412653INF1 510437IN 650725IN2 RU1152NM02 YN4252 YN4821 M256517203 876259NU01 CY1015NM01 849010NU01 0910262335 06109NUC02 06014NUC02 34329NUC01 35003NUC05 34017NUC02 RU1284NM01 RU2050NM01 RU2527NM03 RU3424NM01 PPR97306 LV4002NM02 A5197934 B5119121 F5119151 B5174320 IR1049NM01 00105NUC03 00393NUC06 00131NUC03 00133NUC21 10448NUC04 00373NUC01 V2147210 V7406617 M4159235 V6414104 B1650218 NPV15964 MPX52309 DE492A51 MEX68919 YE364417 DK1065NM05 HLUE01NU01 493519NU02 662608NU01 CS1021NM03 CS1318NM01 110064NU01 150017NU05 190171NU05 110009NU01 M23084315 ZA2261NM01 701234INF2 MPX99201 414384INF A5719812 M4145143 M54606103 M40345193 0856260023 0834260003 26329NM1 2962725INFINIA 3882942310MNCTR 0834260008 2605823INF 0835260013 941235INF 763MRCYINFI 763UNTYINFI 920738INF 630801INF 732292INFINIA 623478NM2 214820INF1 972498INF 941766INF2 716366INF 973625INFINIA 865545INFINIA1 937278INF 601376INF1 941637INF 865947INFINIA1 614722INF1 302428INF 318681INFINIA 626359INF1 626359INF2 518828INF 972969INF 717627INFINIA 814533INF 812842INF1 906776INF 404712INF 781979INF1 615768SCNM1 731644INF 507345INF1 919934INF 847535INFACQ 863679INF1 863687INF1 863687INF2 717544INFINIA 801408INF 989723INF2 937328INF2 860350INIF 704783INFI1 704783INFI2 704783INFI3 937208INF2 908522INFINIA 717782INF PITTINF4 704384INFI2 704384INFI5 704384HAWK1 262363INF 661633NM1 585922INF1 843724INF 715839INF 858554INF2 605333INFINIA 740356INF1 210921NM1 415222IN1 205408INF 203325INF 203325INF2 504873INF 573686INF1 907562NM1 540213INF1 601978INF 956350NM1 316962WI 01002NUC04 0856260025 O005NU14 Y004NU08 H002NU01 PPR08202 0843260029 2543334INFINIA YN1200 A5153612 A5197927 C5120915 A5172907 A5118056 083026862101014 083026602101643 083026862100874 083026822100376 IE1100MN01 IE1029MN05 IE1053MN01 HU1039NM02 0828260003 0828260005 00109NUC01 00253NUC02 00216NUC11 00260NUC03 00348NUC02 IE1510MN12 00331NUC02 UE282633 YE364413 783348NU01 450654INF2 709651INFINIA 604520INFINIA1 604520INFINIA2 519749INFINIA 418275INFINIA 905731INFINIA 905855INFINIA 416633INFINIA 416756INFINIA 905372INFINIA 705759INFINIA 306766INF2 306766INF1 306655INFINIA 519631INFINIA 604588INFINIA1 604588INFINIA2 604278INFINIA2 604875INFINIA1 082426040030 082426210013 082426120011 082426200003 082426150012 082426130025 082426130020 082426160025 082426080010 082426100028 082426030020 082426120007 082426030021 082426130024 082426080012 082426130021 082426310015 082426160026 082426050004 082426030022 082426010014 082426140016 082426070018 082426110004 2812777 110034NU04 408259IN1 508828INF 815741INF1 815741INF2 970350IH 757398INF1 916537IN 415677INF 619482INFINIA 941629INF 530876IN 414805QUA 262574INFIN 408559IN1 608775INF1 608775INF2 262670INF 928855INF 920684INF 610437INFINIA 925INF 509946INF 310543INF1 602344NM1 603650INFINIA1 623848NM2 409727NM1 989723INF1 937328INF1 215952INF 516570INF 501620INF 831755IN1 928537INF 937208INF1 225765INF1 704384INFI4 405271IH1 801588INF 516622INFINIA 303320IH 509474INFINIA 626570INF1 858554EDCINF 858554INF1 757668INF1 650367IN1 480301NM1 734246INF 314525INF1 713785SLINF1 817882INF1 410955INF 205939INF 907562NM2 714456INFINIA 608263INF 608263INF2 650725IN 801584INF1 801584INF2 415750IN1 305575INF1 909825INFINIA 540536INF1 615322NM3 410605INF 206223INF 0856260024 0843260032 083026602100924 519752INFINIA 450654INF1 604520INFINIA3H 514842AINFINIA 604588INFINIA3H 604588INFINIA4H 604278INFINIA1 604875INFINIA2H 082426220007 082426200004 082426210015 082426270005 082426070019 082426190014 082426160027 082426180009 082426070020 082426120013 082426130026 082426180007 0910262170 0910266042 0910267010 MA1020NM01 KW1001MN23 PK1278NM01 IR1501NM01 UK1110NM01 RU2526NM01 RU2199NM01 RU2527NM02 NO1016MN16 NO1068MN07 DVT0138 LDD0431 LDD0433 HGL0233 HLV0334 A5367805 A5112411 A5120724 A5109126 A5198016 A5111127 A5115111 A5189714 IL1020NM25 IE1029MN04 GE1004NM01 10181NUC06 00109NUC04 00311NUC01 01367NUC01 00361NUC05 00139NUC05 00137NUC01 01243NUC02 00379NUC01 00318NUC03 70060NUC12 00187NUC01 00440NUC09 00100NUC02 77137NUC01 77139NUC05 M2846905 C4191749 FI1153MN01 FI1019MN01 FI1003MN06 FI1003MN05 DPN00002 NP739716 CE561221 FPG86405 HC0074NU01 PC5995NU01 485520NU01 CS1277NM02 900010NU06 110022NU03 300013NU01 030209NU02 AH5689NU04 ZA1807NM11 ZA1806NM12 ZA2008NM04 ZA1808NM13 ZA1835NM24 ZA2006NM04 505262INF 651241INF1 619229INF 781477INF 706651NUC 262948INF 507434INF1 256761INF 727893INF 302744INF1 757398INF2 518626INF 956687INF2 419227I1 419227I2 VASINF 804323INF1 775423INF1 361572NM1 281338INF1 915521HNM1 503435INF 845794INFINIA 6525011INF1 925370IN 361985SNM 406238INF 812426INF 757889INF1 719333IH 207255INFINIA 678474INF 703698INF1 626573INF1 818409INF1 806GRACENM 937374INF1 706494HNM 801501INF1 801314INF1 801IMCINF1 925785IN 410550INF 704660HAWK 262741INF LGMCINF2 435750INF2 510400IN 713242INF1 713ACCINF1 228865HWK 262767INF 916983INFN1 530225IN 937390INF1 218333INF1 701234INF 626898INF1 727461VG 212241INF3 402559INF1 760873NUC 504838INFH 315592INF 704384INH1 915577NM1 706291HINM 956971NM1 802775INFINIA 503561INF 757388INF2 913676SMIM 508674INFINIA 608791INF 918494INF1 707963IN 410337INF 262334INF 901495INFHAWK 414489INF 801268INF1 209526IN 714953INFINIA 303399IH 254743NM 404321INF 304264INF 850494HAWK 928442INF AC001NU14 600042NM05 NO1088MN09 ZWL0437 ALM0131 0850260074 0850260075 YN1601 YN1590 YN1597 YN1599 YN1592 YN1600 YN1596 YN1591 YN1595 YN1593 YN1598 YN1594 A5279301 A51149103 A5306502 D5111602 083026003811611 083026822100655 IL1069NM11 IL1331NM01 0835260010 0835260007 0828260006 00371NUC04 00130NUC03 00136NUC03 00234NUC05 00318NUC10 10497NUC03 M9164758 M4135145 B4155415 M4198189 M9319116 FI1000MN04 FI1064MN01 EEF51540 DK1026NM08 HC0863NU01 403382INFINIA2 613969HAWKEYE 418589INFINIA 819595INFINIA 905883HAWKEYE 418649NUC1 905813INFINIA 403289NUC1 604434INFINIA 250785INF1 514495INFINIA 819357BINFINIA 519685INFINIA 604531INFINIAH 506739INFINIA 306655INFINIA5 705674HAWKEYE 709637INFINIA1 082426290005 2638808 190057NU05 190187NU01 080026NU08 210036NU06 190205NU06 0910263143 0910263161 0910263166 0910263157 0910265050 0910266053 0910263159 AH5293NM04 AH5249NM04 PK1355NM01 KW1001MN25 KW1006NM01 45001NUC01 615896NM1 507402INF1 920456INF 814889INFINIA 480323INFRM3 435781INF1 540332INF2 540332INF1 262329INF 262434INF1 262434INF2 918376INF1 205783INF1 920288INF 217223INF1 217223INF2 814362INFINIA 802257INF 718250INF1 617296INF 937440INF1 916537IN2 607274INF 607274INF2 702360CHNM 423553INF 212989INF1 559225IN 315425INF 412692INF1 412692INF2 513585INF 361881SSINF1 785462CI 423472INF 972540INF 512397INF 507457INF1 414649INF 212686INF1 804675INF1 480512INF1 901523INF1 901523INF2 571231HAWK1 423778EDINF 423778MMINF 954735INF1 615327VANM1 615893NM1 920568INF 828315HWK4 865271NM1 518926INF 937832INF1 508427INF2 602239INF1 717633INF1 717633INF2 570501INF 781340INF 781340INF2 781340INF3 816271SJINF 801ALTAINF2 801IMCCARD 801IMCINF 801SLCINF 801357INF2 701857NM 724357INF1 703858HAWK 626915INF1 731425INFH1 731425NMIC1 731425NMRM 701952NM 215728INFINIAJ 732776INFH4 732321IH4 JOHNINF 408851IN 415838IN 4082IN 262656INF1 262741INF2 801299INF1 801408INF2 610402INFINIA2 718150INF1 6502IN1 540741INF1 NM156449 801387INF1 478633INFINIA2 972596INF 337981INF 713456INF 410822HK1 610278INFINIA 916453IN 608756INF 901516NINFHK 254519NMINF 541296HK4 718405INF1 231935INF 615769NM1 COR359309 COR369576 770751INF 817255INF 662377INFINIA 937438INF 901516UINFHK 718334INF1 718334INF2 718963INF1WH 718616INF 507OLMINF1 ORMCINFINIA1 337289INF 270688INF 404605INF 803329HAWK 802388INF 570621INF 425261INF 541387INF 248465INF 360PSPHINF1 703689INF4 919784INF1 401444INF 801RHINF 732937INFINIA 540689INF1 540689INF2 503561HK4 281420INF 505609INFINIA 408315IN 480882INF1 479441INF1 864SPAHK1 864SPAHK2 864560HAWK1 217528NUC 314525INF2 215427INFINIA 920738INF1 920738INF2 864675HAWK 516562INFINIA1 757886INF1 316268VCFI 313343INF1 484503INFINIA1 215710INFINIA 317338HAWK 540741HAWK1 228523HWK 916782IN1 916782IN2 215707INFINIA 832824INF 816404INF1 920729INF 607763INF 202715INF4 210358IHE 916703IN2 312996INF 913588INF 913588INF2 903UTINF 419383NM1 832505NM1 214370INF 813USFINF1 828298HAWK1 828298HAWK2 650858IN1 650858IN3 801584INF3 937268INF1 520VAINF1 713794INF 713794INF2 562826INFINIA 718630INF1 305575INF2 559353IN 540536OCHAWK VVMCINF1 973676INFINIA 502287INF VCWESTINF 757395INF1 206223INF2 301714INF 863680INF1 513298INF1 513298INF2 623207INF 262687INF 414325INF 570552INF 586416INF 203688INF 0853260040 0853260025 0853260036 0853260032 0853260030 0853260035 0853260029 06051NUC04 0856260030 0856260032 C001NU06 C001NU10 N001NU02 N001NU06 AC001NU18 RU3314NM01 RU1018NM01 RU3508NM01 PER03520 PER08009 787653INFINIA2 PL1143NM06 PL1692NM01 600042NM06 0920269087 0920269092 0920269093 NO1068MN09 APL0232 ZTP0133 EMM0131 0834260012 2750751INF NMCR-17849 2766055INFHE4 36INF2753220 0850260108 0850260111 0850260096 0850260119 0850260117 0850260098 YN4237 YN4225 YN4248 YN4245 YN4243 YN4288 YN4223 YN4224 YN4239 YN4241 YN4242 YN4255 YN4236 YN4229 YN4300 YN4221 YN4250 YN4238 YN4228 YN4231 YN4226 YN4240 YN4234 YN4235 YN4222 YN4230 YN4244 YN4220 YN4219 YN4218 YN4227 YN4232 YN4233 YN4260 YN4822 A5127292 B5618331 A99263311 A186363001 A5123523 A5128755 A5129959 B5315345 A5118088 083026202101361 083026022002299 083026062102318 083026842101377 083026202100886 083026802100537 083026867892981 083026600020711 083026002101088 083026022002291 IL1043NM20 IL1062NM26 IL1059NM07 IL1020NM31 IL1018NM08 IL1041NM18 IL1041NM22 IE1110MN01 IE1085MN05 0828260015 0828260011 0828260009 0828260019 00002NUC02 00141NUC06 00065NUC05 00197NUC11 00433NUC09 00487NUC04 00374NUC05 00257NUC06 00257NUC15 00018NUC04 IE1510MN16 00240NUC05 00053NUC09 00383NUC03 V2943412 M4159460 M4160449 M4163034 M4111216 X105967809 V2728109 H4858974 M4194031 M4480229 B1768001 C4191765 M4184856 M2645705 M204493801 M4191430 M4144340 M1106608 M4143953 M7411101 X119197203 V8572204 S4160079 M4496943 FI1010NM01 FI1029MN01 EE1019NM02 ME208350 UE282648 ME244391 ME244393 YE626937 FEG46134 DE6588112 EE238526 UP285A41 DEN01723 DEN01725 DEH13556 DE528467 FEE12426 NE209938 FEB33835 18076INFINIA DK1065NM04 DK1023NM03 HC2720NU02 PC3970NU02 485520NU07 PC1268NU03 PC2261NU02 HC4480NU01 PC3964NU02 600044NM07 CS1052NM08 600131NM05 600055NM04 CS1008NM03 260010NU05 529150NU03 722050NU01 403251INFINIA1 403382INFINIA1 403670NUC8 519752INFINIAH4 450654INF3 450468INFINIA 514371INFINIA 819378INFINIA 902567NUCINH4 709651INHE4A 403541INFINIA 905813INFINIA2 403289NUC2 709737INFINIA2 709737INFINIA3 604557INFINIAH1 604557INFINIAH2 604557INFINIAH3 604520INFINIA4H 905521INFHE4 905577INFHE4A 905577INFHE4B 204787INFINIA2 514252AINFINIA1 514252AINFINIA2 514252AINFINIA4 514252AINFINIA6 514842AINFINIA2 450746INFINIA 780489INFINIAH4 780489INHE4B 780489INHE4C 519685INFH4 705759HAWKEYE 403777INFINIA 403777INFINIA2 306655INFINIA3 514340INFINIA 250339INFINIA4H 416864INFINIA1 416864INFINIA2 416469INHE4A 416469INHE4B 250565NUC4 519663INFINIA2 604228INFINIA1 250370INFINIAH4 082426040039 082426210016 082426160034 082426200007 082426100033 082426100037 082426190015 082426150024 082426090018 082426110009 2768147 2694593 NMINDTCRL0227 2621801 1153389 030240NU07 030078NU13 190057NU10 030419NU09 190282NU09 030232NU10 030151NU12 190052NU06 190194NU01 030388NU04 0910262236 0910262288 0910262291 0910262210 0910262269 0910262307 0910262217 0910262276 0910263198 0910265066 0910264081 0910264089 0910264102 0910264112 0910264123 0910266050 0910266067 0910266063 0910267015 0910267020 0910262263 0910263210 0910263135 0910262255 0910265068 0910264072 0910264095 0910264121 0910264077 0910264083 0910264105 0910264107 0910264126 0910262312 0910263204 0910262205 0910262214 0910262220 0910262295 0910264075 0910264091 0910262239 0910262229 0910262241 0910262225 0910262227 0910262249 0910264100 0910263207 0910262244 0910262280 0910262301 0910262257 0910262285 0910265063 0910262293 0910264115 0910262266 0910262279 0910262332 0910264137 0910263220 0910265072 AH5689NU03 AH5117NU02 AH1908NU01 AH4660NM06 AH4307NM05 2954INFINIA ZA2246NM01 ZA2212NM02 2723INFINIA 818409INF2 IL1041NM28 IL1041NM29 IL1042NM09 1577INFINIA 614722INF2 319356INF 809758INFINIA PL1143NM03 00053NUC06 FI1021MN01 FI1023MN02 DK1029NM05 DK1022NM05 CS1277NM01 259170NU02 082426040041 082426090016 082426250003 082426120015 030232NU13 919684INF1 082426040036 082426100036 082426150013 082426150015 082426130023 082426160030 082426040038 082426150019 082426080014 082426150016 082426150018 082426120016 082426150014 415300IN 513636INF 402559INF2 916781IN 415353IN 916703IN1 787758INFINIA2 78NMIH2564713 0920269081 0920269079 NO1000MN03 NO1070MN07 AMS0338 INF2649553 2660585INF 2633201INF YN1744 YN1743 YN1745 YN1742 A5547414 A5152964 A5114292 A5107756 B5357630 083026202100317 083026842101817 IL1028NM26 0828260007 IE1564NM01 2612588INF2H DK1026NM07 427459NU02 2585033INF 519685INFINIA2 506544NUCGE 2775945 2555007 AH3701NM05 A5172908 209831IN 671USNHINF 903416INF YN1650 YN1641 A5649008 A5216823 A5128757 A5124139 H2100NUC02 080004NU11 A5224207 919684INF2 650858IN2 600092NM10 PL1003NM03 4716INFINIAHE4 YN4830 YN4900 YN4820 YN4249 YN4819 YN4818 YN4825 083026006866397 083026002000938 2721482INF 082426100035 082426270007 082426050005 082426090022 082426190017 082426120018 082426230016 082426160035 082426100032 082426040042 082426170003 082426140022 082426070025 082426210017 082426120019 082426110008 082426290006 082426140019 082426230015 082426070023 082426100038 082426090024 082426140018 082426100041 082426090017 082426160033 082426090020 082426160031 082426310022 082426100043 082426130027 082426090021 082426080019 082426110006 082426070024 082426080018 082426310021 1299296 2769200 AH5844NM05 519749INFINIA2 082426310016 082426120021 082426130038 H010NU04 E001NU16 NO1054MN01 NO1116MN09 DHG0539 A5181660 00439NUC08 220826NU01 ZA1835NM25 703558INF 214820INF2 718584INFINIA 610402INFINIA 402354HWK 920272INF2 713785SLINF3 0920269082 2864298INF 0850260109 0850260084 0828260017 0828260018 0828260013 2694427INF 2646005INF 819563CINFINIA 403229INFINIA 905358INFINIA 204787INFINIA 250754INFINIA 250754INFINIA2 613761INFINIA 082426150021 082426160032 2760723 0910264067 0910264069 0910264098 0910266045 0910264060 787848INFINIA 773884INF 210575INF1
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
FDA Determined
Cause 2
DESIGN: Device Design
Action GE Healthcare sent an " IMPORTANT PRODUCT INFORMATION" letter dated March 6, 2012. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology/Cardiology. The letter described the Issue, instructions, Affected Product Details, and Product Correction. For questions contact your local GE Healthcare Service Representative or call the GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other Countries 262-896-2890.
Quantity in Commerce 2180
Distribution Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.
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
-
-