GE Healthcare, LLC: GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

Recall number

Z-0370-2019

Recalling firm

GE Healthcare, LLC

Product

GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

Status

Terminated

Initiated

2018-09-14

Posted

2018-11-14

Terminated

2020-10-08

Reason

A detector can detach and fall.

Root cause

Other

Action

GE Healthcare will inspect and if required correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the inspection.

Quantity

1,166

Distribution

United States: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,Guam,MA,MD,ME,MI,MO,MS,MT,NC,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR, RI,SC,SD,TN,TX,UT,VA,VT,WA,WI AND WV International: Albania, Argentina, Australia, Azerbaijan, Belgium, Bosnia ,Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Colombia, Cyprus, France, Germany, Greece, Guatemala, Honduras, Iceland, India, Iraq, Italy, Jamaica, Japan, Kenya, Korea, Macedonia, Mexico, Namibia, Panama, Peru, Philippines, Portugal, Russia, South Africa, Spain Switzerland, Taiwan, United Kingdom, Turkey, Venezuela and Vietnam

Lot, serial or model codes

System ID #: 334428MG, 256235NM2, 251660KWMG, 251410IMCMG, 501776MG, 870836MG, 870364MG, 479443MG1, 870261MG, 501520MG,  501614MC, 501224MC, 501686MG, 501202WMG, 870541MG, 501380MG, 479751MG, 501484MG, 479314MG2, 501474MG, 480393MG, 928758NM, 480425NM1, 602588NM2, 520GVHMG, 480830NM1, 928699MG, 602251NM2, 602588NM3,623478NM1, 480820NM1, 602392NM2, 623933NM1, 602870NM2, 623879NM1, 602964MG1, 480838MG, 480844NM1, 714456MG, 661663MG1, RADNETNM170, 661322MG, 909390MG, 707464NUC, 714979MG, 510792MG, 916537MG, 5668, 1572, 951698MG1, RADNETNM1732, 949863MG, 818885MG, 805988MG, RADNETNM1726, 626397MG, 30244MVC, 209835MG, 916781MG1, 415600DAVMG, 831759MG1, 831759MG2, 619287MG, 707576MG1, 408278MG1, 707546MG, 209944MC1, RADNETNM175, 310543MG, 310214MG, 707463MG, 818782MG, RADNETNM171, 626814MG, 530741MG, 30337NM, 719275MG, 719475MG, 970565MG, 303398MG, 303629MG, 303715MC1, 303715MC, 303673MG1, 303426MG1, 203797NM5, 203797NM7, 203797NM6, 203797NM4, 860364MILL, 860496MILL, 203238NM, 202529MC, 407303FAMC1, FHALTMG2, 407SMALMG, 407303FAMG1, FHAPMG, 561642MG1, 561642MG2, 561642MG3, 561742MG1, 813571MG, 718444MG1,  718444MG1, 239432MG, 727461MG, 727446MG, 305446MG, 305461MG, 352564XEL1, 863419MG2, 305529MG, 941473MG, 239938MG, 561468MG1, 850863MILMG, 352333MG, 352331MG, 305820MG, 305826MG, 904389MG, 904202OPMG, 407518MG, 07SMKSMG, 561795MGLW, 863680MG,  863687MG, 941368MG, 561791MG1, 321725MG3, 321725MG2, 305596B84, 305279MG, 305512EXL, 305821MG, 941436MG1, 850678TCMG, 352401WMMG, 352401MC, 352401MNM2, 352871NUC, 407303FSMG4, VACMG, 407SMKLMG, FHORLMG5, FHEMG, 904747MIL, 850747BMG, 850416SHMG, 850912VAMG, 954587MG, 954476MG, 561335MG1,  305251MG, 941342MG, 941951MG, 772SRMCMG1, 850325MG1, 941488MG1, 561798MG, 563927MG, 561863MG1, 407628MG, 407646WPMG, FHWPMG2, 407628MGA, 813991MG, 229312MG, 678762MG, 706208MC1, 404851MC, 403182, 404712MG, 706745MG, 706745MG2, 706625MG,  229276MG, 706278MG2, 404321MG, 706754NM, KAISERSW, KAISERGW, 770677MG, 912384MG, 404669NM, 770297NM1, 912757NM, 912751NM,  912765NM, 770793MG, 912454NM, 229890MG, 770991MG, 404605MG,  229391MG, 478922NM, 478922NM1, 671GMICMG, 808547QP3MG, 712792MG, 641236MMG, 712213MG, 712279MG, 319472MG, 319863MG, 208785MG, 208677MG, 208525MG, 207373MG, 618465MG1, 847382MG, 708783MG, 708923MG, 708923MG2, 630264MG, 708799MG, 630364NMMG, 504459MG, 309449MG, 815741MG, 847360MG, 815968MG2, 815968MG1, 815398MYO, 847933MG2, 847933MG3, 847941MG, 812933MG, 812256MG, 812485MG, 812485MG2, 812485MG3, 765281MG, 812858MG, 812752MG, 812237MG1, 812237MG2, 913367MG1, 620431MG, 620382MG, 913491DMG2 316421MG, 620421MG, 620221WNMG, 606833NMG2, 606833MG1, 606986MG, 270781MG, 270745MG1, 270793MG, 270745MG3, 270706MG, 270598MG1, 606573MG, 606439MG, 606666MG, 502893N6, 502636N8,  502361MG, 606598MG, 270926MG, 606337MG, 270725MG, 502633MG,  606678MMG, 606678NM, 502897MG1, 337898MG, 318473MC, 318473MG1, 225755MG, 225769MG, 225761MG2, 225231MG, 225761MG1, 225358MG, 985732MG, 337462MG, 337457MG, 985839MG, 504549MILL, 985230MG2, 985878MG, 504838MG2, 504838MG, 337261MG, 337521ACQ, 337289MG, 337289ACQ, 337475MG, 504454MG, 504888MG, 504456MG, 504456CCMG, 318371MG, 318812MG3, 318327MG, 337374MG, 504903MG, 504894MG, 337948MG, 318473MG, 318251GCMG, 318254MG, 504447MG, 337363MG, 318648MG, 318345MG1, 617754NM1, 413535MILL2, 413535MILL1, 301896MG, 443643MG, 301698MG1, 301373BEANMG, 301634MC,  301373MG, 207351MG, 586445MG, 313593MG2, 517851MG, 313593MG, 248471MG, 810732MC, 810733MG, 517437MG, 906774DMG, 248656MG, 989773MC, 586416MG, 906341MG, 906486MG, 248551MC, 989497MYO, 248945MG, 989846MG, 313295MG, 734671MG, 248828MC2, 313343MC, 248551MG, 248828MC1, 734467MG, 417869DMG, 417326MG, 417358ND2, 660259LMG, 409690MG1, 816271SJMG, 573468MG1, 417678MG, 636528MG1, 417256MG, 662712MG, 228467MG, 601824NM2, 601855MG1, 601853MG1, 228818SRMG, 228864MILLMG, 228863CHMC, 601740MG1, 362258MG, 662627MG, 662289MG1, 601815UMG1, 601853MIMG1,  601849MG1, 228809MG2, 662349NM, 662349NM1, 662349NM2, 662615MG1, 662841MG1, 601883NM2, 601883NMC1, 601735MG1, 406657DMG1, 406728MG, 919894MG1, CHOWANMG, 910483ACQ, ALLIANCESP37, 919784MG1, 336599MGA, 336718FMG1, 336718FMG2, 402483MG2, 402486MPR, 402473MG, 402873MG, 603432MG, 201858MC, 908277MG, 609465MG, 973625MG, 973989MG, 973702MG, 732548MG, 732390MG, 609655MG, 609358MG, 201795MC, 609978MG, 973898MC, 732545MG, 973971MG2, 856778MG2, 732745MG, 732745MC, 732745MG2, 973877MG2, 973877MG3, 973579MG, 732970MG, 973678MG, 201967MG, 973365MG,  201470MG, 201831MILMG, 732381MG, 732530MG, 609653MG, 732923MG2, 732923MG1, 505492MG, 505662NUC, 775738NM, 702564NM, 702384MMIL, 702896MG, 702240MG2, 702732MG2, 702240MG, 702732MG, 702346NM1, 775323MG1, 518438AIMG, 631968MG, 516829MG, 607337MG1, 845278MG, 718518MG, 718518GENIEXY, 718951MG, 718444MG, 718567MG, 718692MG, 718758MG, 718680MC, 716884MG1, 716857DW, 716895MG, 631277MG, 315SOSMG1, 845647MG, RADNETNM1745, 718869MG, 718762MG, 718670MG, 718670ENT, 718544MG, 516222MG, 315824MG1, 631351MG2, 631425MG, 718206MG, 716487MG, 716447MG, 716298MG, 315376LCMG, 315798MG1, 516775MG, 516562MC, 516327MC, 516869MC, 516562MG1, 212252MG, 212523MG, 212420MG, 212288MG, 212326MC, 212737MG, 212535MG, 212241MG, 212420MG1, 212420MG2, 212523MG1, 607432FMG, 631447XELERIS, 845858MG, 585922MG1, 845794MG, 315338MG1, 518347SMG, 914366MG2, 631726MG, 718876MG, 914368MG, 585786MG, 716630MG, 914964MILL, 330665MG, 513686MG2, 513686MG1, 21636307MG1, 419342MG, 614228MYO1, 740380MG1, 740845MG1, 614393NM, 440776MG, 330757MG, 440329MG, 419824NUC3, 330841MG, 330841MG1, 440414NM, 405779MG1, 405359EMG, 580355MG1, 580355MG2, 918683MG1, 405271OUMG1, 918523MG1, 918256MG, 918485MG1, 541OIT111A, 541994MG, 503535MG, 814946MG, 814949MG, 610954MG1, 610770MG1, 610954MG2, 215538MG, 814362MG, 215785MG1, 570645MG1, 215345MG1, 215345MG2, 215663MG1, 724752MG, 814868MG, 717657MG, 814247MG, 814532MY0, 814534MG2, 814837MG, 717820MG1, 412678MG, 724258MG, 215728MG1, 215707MG1, 215662MG1, 215331MG1, 215662MG2, 215728MG2, 215662MGP, 215827MG1, 412623MG, 570882MG, 724627MG1,  215648MG1, 401782MG, 864442MG, 803438NM1, 843784MG, 843681HHMG, 803431MG, 864529MG1, 864849MG1, 605224MG, 605322MOB1, 605882MILL, 931393NM1, 423877MG, 423778MG3, 423778MG2, 931551MG, 423778EDMG, 423775MG, 618357MG2, 423855MG, 615791MG, 423837MG, 423784MG, 423531MG, 423693MG, 865541MG, 865471MG, 865541ETCMG, 865471MG2, 731968MG, 731352MG, 731352HMG, 901346MG, 901226MG1, 901726MG, 901523MG, 423522MG, 615322NM1, 615583RRMG, 423481MG, 865481MG2, 865938MG, 731926MG, 806354NWMG, 817472MG, 217532NM1, 817599MG, 281837ALTUSMG, 409883MG, 979337MG, 361694DNM, 214879MG, 903675MG, 918825MG, 512942MG, 618357MG1, 618357MG3, 940384MIL, 972875MG, 817926MG, 817336MG, 817430MG, 972731MG, 409772NM4, 469999MG, 903408MC, 713785SLNM2, 713790LMC1, 936438MG, 281420MG2, 713463MG1, 713ACCMG1, 713785SLNM1,  713797NUC1, 972932MG, 214420MG, 972420MG1, 972420MG2,  903315MG, 915520MG, OPENMG, 915333MG, 713948MG1, 214739MC, 972781MC, 512446MG, 210572NM1, 210704MG, 210223MYO, 817778MG, 936266SLNM1, 281338MG1, 940766MG, VVMCMG1, 801492MG, 801357NUC3, 435722MG, 801268MG, 509747IMG2, 703558MYO, 434982MG1, 703698MG, LEEMG, 703689MG, 434517MG, 360754MG, 253697MG, 509942NUC, 206548MG2, 206223MG, 406782MG, 509525WWNUC, 608930MG, 608884MG, 262697MG, 920684MG, 414219MC 414647MG2, 414874MC, 262338MG, 414645MG, 414805MG, 414874MG, 608324MG, 262ISCVG, 262574MG3, 608745MG, 608723MG, 608776MG,  608647MG, 608873MG, 920262MG, 414569MG, 262544MG, 262574MG1, 262574MG2, 414259MG, 414777MG, 304255BMG1, 304637MG, 304697HNM, 304757NMG1, 304424NMG1, 304424GENIE, 304357MG, AL4009NM01, NM8464, 1795MILLMG, 3752MILENIUM, 94126MG, 910263209, 910262299, 910263176, 910262207, 910263214, 910262283, 0910263200, 910262098, 391884NU01, AH5117NU01, AP5816NM02, AP0338NU01, AH5653NU01, AZ4003NM01, 110093NU05, 210036NU04, 080038NU05, 070050NU02,  030006NU03, 030091NU06, 040158NU05, BA4030NM01, NM0791, 1316159, 2722518, 2837776, NM0964, 2702126, 2702287, 1189654,  2599328, 2657483, 2741212, 2954642, NM50904, 2685607, 78072, 2606818,  46200, 2854964, NM51699, 1339117, 2816349, 1337080, 1337071, 1319161, 2814934, 2726551, 2827678, 2833281, 2730895, NM639, 2730898, NM51698, 13645, 1205380, 1184323, 1218294, 2575410, 2614287, 2753164, 3082, NM51702, 13568, 13730, 53477, NM1446, 2540459-1, 24716, 14532, 2697006, NM08391, 2723506, 1167249, 2689272, 13831, 2799221, 2804878, NM51696, NM1462, 1186798, 1293331, 1343737, 1343738, 2814304, 2592294, 2836370, 2836369, 2628142-1, 780489MG2, 250545MG, 250727MMG, 780489MG, 416667MG, 705324MG2, 204942MG, 902496MG, 905727MG, 905791MG, 905791MG2, 416231MG, 519767MG, 905577MG, 705324MG, 519646MG2, 613727MG, 905895MG, 905684MG, 905723MG, 705745MC2, 705745MC, 416299MG, 416299SNMG, 519428MG, 807343CNUC3, 416813MG, 416284MG, 416465MG, 416438MG, 519206MG, 905430MG, 905576MG, 519254MG3, 519258MG, 519254MG1, 416593MC, 819357BMG,514842AMG, 514933MG, 514340MG, 514842AMG2, 514934BMG2, 514934BMG, 418628AMG, 819822MG, 32501257NM1, HNVNM1, 24205NM1 082426100010, 082426010005, 082426030006, 82426200006, 82426100014, 82426100004, 82426190009, 82426100022, 82426020003, 82426020004, 82426310018, 82426060002, 82426110005, 82426080013, 82426170002, 82426040040, 82426080015, 82426050006, 82426130028, 82426080017, 82426100039, 82426070026, 82426210018, 2802765MG, 2750131MG, 2625368MILL, 2751497BMG, 2866379AMG, 2866379BMG, 10094MILMG, 2774246MG, 2890503MG, 2751497AMG, 33815MMG, CY1114MN01, V9185605, HC0541NU02, PC3837NU03, PC3838NU04, 878339NU01, 878339NU02, PC3838NU05, PC3844NU03, 393115NU01 PC3874NU02, PC0850NU02, 543871NU01, HHAM02NU04, 540186NU02, 136413NU01, PKAI01NU03, HC5284NU01, 427459NU03, PC7625NU01, PC3720NU02, PC0995NU02, PC1961NU01, 673799NU01, PC1837NU02,  PC2541NU03, PSAN01NU01, 509585NU01, HC0853NU02, H1349NUC01, H5059NUC01, H5899NUC02, H2049NUC06, H4390NUC01, H4262NUC14, H4105NUC06, H4935NUC01, H4093NUC03, H17642NUC4, 2767676, NM1471, 24574562NU, IS1002MN02, 83026843025441, 083026242100654, 083026240001716, 083026002002015, 83026102101026, 083026203255516, 83026002100286, 0002649858, 08302603017002, 083026802100897,  83026602100758, 083026604546814, 83026042100775, 83026042101847, 83026802101537, 083026800017715, 83026842100997, 83026841019810, 83026002101937, 083026022002249, IQ1575NM01, A5633804, A178956301, A268005103, A5132121, A5330712, A5162252, A5367605, A5165826, A5165828, A5186208, A200283801, B120559401, B5365420, B5365421, B5531603, A5251115, A5156933, A5142912, A5634503, A5151505, A5367807, A5124141, A397803504, A5636003, A5634102, D5822409, D5822413, C5123640, C5123632, A5114257, A5323502, A5115236, A5295811, A5278110, A5278112, A5138109, A5239806, A5660901, A5555211, A5634607, A5690905, A5690902, A5155147, A5221304, A5242702, 2543455NUCMED, YN1086, YN0536, YN0494, YN0906, YN0457, YN0830,  YN2047, YN0903, YN0899, YN1094, YN0402, YN1103, YN8101, YN0831, YN0900, YN0433, YN2060, YN0394, YN0404, YN1090, YN2043, YN2046,  YN0905, YN1092, YN2044, YN0627, YN1098, YN0537, YN0399, YN0828, YN2050, YN1099, YN1101, YN1102, YN0460, YN0466, KE1000NM01,  850260036, 0850260085, 850260053, MC1024NM01, 2615851MG, 2615865MG, 14NMMG2693065, 2750750MG, 2837597MG, 5449MILMG, 2762247MG, 589603MC, 2879861MG, 2825084, 2847091, 2860129, 8619NUCGS, 2851996, 2851997, 2851998, 2851999, 2859205, 2860131, 2860133, GELB0221MILLMG, NM50993, 870299MIL, 4422MIMG,  51485MG, NM51559, 2641677MG, 2763057MG, 70896MILMG, 9925MILMG, 4000711, NA1019NM01, 2673523MG, 2545894MILLEMG, 843260011, PER00431, PER10509, PER10516, PPS09402, PER10506, PER12107, PPR12211, PER08005, PER08614, PPS06901, PPR48810, PPR48801, PPR69605, 787653MILLMG, 809746MILLENIUM, 787757MILLENIUM, NM2595306MMG-1, RU1148NM01, RU1041NM01, RU1086NM01, RU1488NM01, RU1013NM01, RU1085NM01, RU1213NM01, RU1224NM01, RU2966NM01, RU3143NM01, RU1105NM01, RU1755NM01, RU1021NM01, ZA2425NM01, ZA2192NM01, ZA1829NM05, ZA1841NM04, ZA2391NM01, ZA2230NM01, ZA2693NM01, ZA2225NM01, ZA1818NM04, ZA2694NM01, ZA1442NM01, ZA2024NM04, ZA2692NM01, ZA1811NM06, ZA2813NM01, DPN43202, MPX43128, MP842028, MPX52304, MP221252, GPQ18703, GPQ14600, DEL26413, FP721A04, FP246604, MP601315, YP231727, FPG62103, FPG77501, NP473620, NPV15928, EEP03901, 750140NU01, 107010NU03, 853940081, 853260059, 0853940079, E06001NU03, 06008NUC07, 06002NUC05, 06002NUC06, 06004NUC02, 06052NUC01, 06063NUC01, 06074NUC01, 06087NUC01, 31015NUC01, Not Available, 34006NUC02, 34057NUC03, 34268NUC01, 34434NUC01, 46021NUC01, 55019NUC01, 67016NUC01, 00362NUC02, 38853104NMMET, 3882684835MNMET, 388553393NMMET, 388260005, 859260005, 859260007, and 859260006.

510(k) numbers

["K962738"]

PMA numbers

not on file

Product code

KPS

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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