Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall GE Healthcare Millennium MG

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


New Search Back to Search Results
  Class 1 Device Recall GE Healthcare Millennium MG see related information
Date Initiated by Firm September 14, 2018
Date Posted November 14, 2018
Recall Status1 Terminated 3 on October 08, 2020
Recall Number Z-0370-2019
Recall Event ID 81339
510(K)Number K962738  
Product Classification System, tomography, computed, emission - Product Code KPS
Product GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Code Information 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. 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-312-7277
Manufacturer Reason
for Recall		 A detector can detach and fall.
FDA Determined
Cause 2		 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 in Commerce 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
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 = KPS and Original Applicant = GE MEDICAL SYSTEMS
-
-