FDA · Medical device recall

GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System… and 2 more products

Nov. 21, 2018 Class I

Date: Nov. 21, 2018
Risk class: Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: A detector can detach and fall.
Distribution pattern: 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

3 products in this recall

GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System

Product: GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Quantity: 276
Codes and lots: System ID #: 0002910670AX, 0890013983, 0890079382, 0890079382, 201461MYO, 201858MYO, 202464MYO, 202741MYO, 203483MILL, 203688MYO, 203797NM13, 205739MC, 207641MYO, 209524MS, 209944MS, 212420MS, 212420MS1, 212535MS, 212777MS, 212870MS, 215624MYO, 215676MYO, 215707MYO1, 228523VAMS, 229386MYOS, 248937MYO, 252331MC2, 256341NRM2, 256549MYOS, 270465MYO, 270886MG, 276964MYO, 281313MYO1, 281477NM1, 301884MG, 301905MYO, 302322MG, 302733MYO, 303341MYO, 304256MYO, 304263MYO, 305446MC, 305512MC, 305538MC, 305666MC, 316261KCMC, 316858GMC9, 318574NM, 318728MG1, 318812MG2, 318927NM, 325574MG, 334793MYO1, 334793MYO2, 334821ACN, 337491MYO, 352333MG2, 352564MG, 401729MYO, 401829MYO, 402315MC, 402NHIMC, 405359EMY, 408795MY1, 414219MYO, 414ISCGACQ3, 416231MG2, 416465MYO, 416465XEL1, 416763MG, 417847MG, 423648MYO, 423778MG1, 435734MG, 440326MC3, 443481MYO, 478453NM, 478929MCV, 480279NM1, 480288MG, 480425NM2, 480505NM1, 480835NM1, 501202SMG, 501278MYO, 502226MG1, 02587MYO, 502893N5, 503535MGA, 504329MG, 505462MYO, 505662MYO, 505887NUC2, 508626MG, 508674MG, 508778MYO, 508828MYO, 508992GENIE, 509684MG, 509946KICACQ, 513585MYO, 515358WLMG, 516488MS1, 516520MG, 516599MS, 516627MS, 516775MS, 516789MS1, 516798ELCINT, 516798MS, 519428MYO, 530582MG1, 530674MCV, 541667MG, 561332MG, 561627MC, 570823MC1, 570969MYO, 573334MG1, 580250MG1, 585341MC1, 585442MYO, 585UCVAMC1, 586775MG, 601553MG, 601553MYO, 601982MYO1, 601982MYO2, 602239NM2, 602239NM3, 602978NM2, 605977MS, 605977MYO, 606330MYO, 607432FMC, 608348MG, 610776MG1, 610778MYO2, 614293MYO2, 614464MYO1, 614865MYO1, 615222STNM1, 615329MSN1, 615342CNM, 615342FCNM1, 615449MCV, 615791MSNM1, 615851STH1, 615868MSNM1, 619668MYOSIGHT, 623298NM1, 623815MYO1, 623936NM1, 626308MG, 631447MYOSIGHT, 650617MS, 650991MY1, 661321MYO, 705434MYO, 706722MC, 706733MYO, 713456NM1, 713779NM1, 713917MYO1, 713943HPNM1, 714870MYO, 716488MYO, 716674MYO, 716878MGNUC, 717217MYO, 717344MYO1, 717344MYO2, 718265MS, 718268MS, 718317MS, 718442MS, 718584MS, 718670MS, 718777MS, 718780MS, 718830MS, 718837MS, 718998MS, 724752MYO, 731635MG, 732249MG1, 732281MYO, 732287MYO, 732431MYO, 732660MYO, 732888MYO, 732923MC, 740653MYO1, 760957MG1, 770638MY, 770732MY, 781979MYO, 802524MG, 803256MY02, 803256MY03, 803771MY01, 812949MYO, 813353MYO, 813615MYO, 815759MYO, 816276BMYO, 817250MYO, 817481MS, 817543MG, 818243MC1, 818734MYO, 828586MYO, 843761MC, 847360MYO, 847444MYO, 850696WMG, 850912VAMY, 856374MYO, 856589MCV, 860350MILL, 863687MYO, 864455MYO, 864716MYO, 865984MYS, 870338MG, 870524MYO, 890013983, 890534MC, 904202MYO1, 904202MYO2, 907677NUCACQ, 908273MYO, 908587MYO, 913541OPM, 913684CMG, 914235MS, 914968MYO, 918307MY1, 919684MYST1, 920531MG, 928314NM1, 928505NM1, 928505NM2, 936266SLNM2, 940320MYO, 941412MYO, 941412MYO2, 941792MYO, 949770MYO, 954382MC1, 972475MYO, 972494MYO, 972562MY01, 972562MY02, 973267MYO, 973467MY2, 973543MYO, 973926MYO, 978462MYO, 985643MG, 985873MG2, 985875MG, 989723MYO, A5405211, BCTECH2184116, BCTECH8278, CCCMYO1, CVIMYO, FHGAMYO, FRIMG1, MHLORGENM1, MSSTL-TBD16, RADNETNM1735, RADNETNM1743, RADNETNM1746, and VASMYO
Recall started: Sept. 14, 2018
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Other
What the company told customers: 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.
Recall number: Z-0369-2019

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

Product: GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Quantity: 1,166
Codes and lots: 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…
Recall started: Sept. 14, 2018
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Other
What the company told customers: 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.
Recall number: Z-0370-2019

GE Healthcare Millennium MC

Product: GE Healthcare Millennium MC
Quantity: 18
Codes and lots: System ID #: 870735MG, 928333WMM02, 970635MYO, 203576DNT, 407896FMG2, 954634MG, 316267KCN, 601883NMC2, 910483XEL1, 910296MMG, 908277XL2, 908277MG2, 908218MYO, 918496EN1, 972759CROWNMG, 940566MG, 972434MC,and 972473MYO.
Recall started: Sept. 14, 2018
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Other
What the company told customers: 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.
Recall number: Z-0371-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0369-2019, Z-0370-2019, Z-0371-2019. The agency record governs; check it and the company before acting.

Report a mistake on this page