| Class 2 Device Recall GE Healthcare Infinia |  |
Date Initiated by Firm | December 18, 2024 |
Date Posted | January 10, 2025 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0897-2025 |
Recall Event ID |
96079 |
510(K)Number | K022960 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
|
Product | GE Healthcare Infinia II, Model/Catalog Numbers:
1) H2799ZP;
2) H3000WT; System, Tomography, Computed, Emission |
Code Information |
1) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611;
2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133; UDI/DI N/A, System ID 256543INF1, Serial Number 17182; UDI/DI N/A, System ID 205408INF2, Serial Number 18157; UDI/DI N/A, System ID 256429INF1, Serial Number 17557; UDI/DI N/A, System ID 256327NUC, Serial Number 17900; UDI/DI N/A, System ID 334418INF, Serial Number 17266; UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970; UDI/DI N/A, System ID 205750INF, Serial Number 16802; UDI/DI N/A, System ID 501776INF, Serial Number 17294; UDI/DI N/A, System ID 479463INF2, Serial Number 16900; UDI/DI N/A, System ID 501202INF, Serial Number 16564; UDI/DI N/A, System ID 479967INF, Serial Number 16817; UDI/DI N/A, System ID 479549INF, Serial Number 18319; UDI/DI N/A, System ID 479751INF, Serial Number 16800; UDI/DI N/A, System ID 928214INF, Serial Number 17075; UDI/DI N/A, System ID 520868INF, Serial Number 18289; UDI/DI N/A, System ID 602588INF, Serial Number 17054; UDI/DI N/A, System ID 623406INF1, Serial Number 17064; UDI/DI N/A, System ID 480512INF2, Serial Number 18250; UDI/DI N/A, System ID 623478NM2, Serial Number 16223; UDI/DI N/A, System ID 602406INF, Serial Number 17739; UDI/DI N/A, System ID 602406OPINF, Serial Number 17746; UDI/DI N/A, System ID 480324INF, Serial Number 17150; UDI/DI N/A, System ID 480323INFRM2, Serial Number 17584; UDI/DI N/A, System ID 480882INF2, Serial Number 17998; UDI/DI N/A, System ID 441236INFINIA, Serial Number 16912; UDI/DI N/A, System ID 925779IN, Serial Number 17618; UDI/DI N/A, System ID 805489INF1, Serial Number 17043; UDI/DI N/A, System ID 6502IN2, Serial Number 17962; UDI/DI N/A, System ID 760452INF1, Serial Number 18399; UDI/DI N/A, System ID 415925INF, Serial Number 16863; UDI/DI N/A, System ID 661949NUC1, Serial Number 17730; UDI/DI N/A, System ID 805737INF1, Serial Number 17772; UDI/DI N/A, System ID 323268INF1, Serial Number 17456; UDI/DI N/A, System ID 209385IN, Serial Number 16963; UDI/DI N/A, System ID 951696INF1, Serial Number 16541; UDI/DI N/A, System ID 951672INF1, Serial Number 18114; UDI/DI N/A, System ID RADNETMR547, Serial Number 17183; UDI/DI N/A, System ID 760778INF1, Serial Number 17292; UDI/DI N/A, System ID 661PMCNUC1, Serial Number 17726; UDI/DI N/A, System ID 415222IN1, Serial Number 16437; UDI/DI N/A, System ID 805543INF1, Serial Number 17752; UDI/DI N/A, System ID 310832INF1, Serial Number 17617; UDI/DI N/A, System ID 818907INF1, Serial Number 16648; UDI/DI N/A, System ID 818884INF1, Serial Number 17657; UDI/DI N/A, System ID 303839INF, Serial Number 16790; UDI/DI N/A, System ID 303450INF, Serial Number 18194; UDI/DI N/A, System ID 203797INF, Serial Number 17221; UDI/DI N/A, System ID 203852INF, Serial Number 17320; UDI/DI N/A, System ID RADNETNM1750, Serial Number 17393; UDI/DI N/A, System ID 302733INF, Serial Number 17997; UDI/DI N/A, System ID 610459INF, Serial Number 18560; UDI/DI N/A, System ID RADNETNM1750, Serial Number 16474; UDI/DI N/A, System ID 302629INF, Serial Number 17897; UDI/DI N/A, System ID 302428INF, Serial Number 16559; UDI/DI N/A, System ID 305682INF1, Serial Number 16692; UDI/DI N/A, System ID 352596INF1, Serial Number 16804; UDI/DI N/A, System ID 786308INF1, Serial Number 17368; UDI/DI N/A, System ID 786308INF2, Serial Number 17448; UDI/DI N/A, System ID 904321INF1, Serial Number 17838; UDI/DI N/A, System ID 352333INF, Serial Number 16412; UDI/DI N/A, System ID 954265INF1, Serial Number 18144; UDI/DI N/A, System ID 727863INF1, Serial Number 17418; UDI/DI N/A, System ID 352344INF, Serial Number 17359; UDI/DI N/A, System ID 904821NM1, Serial Number 16209; UDI/DI N/A, System ID 904821NM2, Serial Number 16228; UDI/DI N/A, System ID 904202INF1, Serial Number 17394; UDI/DI N/A, System ID 904821INF3, Serial Number 17684; UDI/DI N/A, System ID 904627INF2, Serial Number 17715; UDI/DI N/A, System ID 904627INF1, Serial Number 17761; UDI/DI N/A, System ID 561744INF, Serial Number 16734; UDI/DI N/A, System ID 561744INF2, Serial Number 18293; UDI/DI N/A, System ID 863679INF1, Serial Number 17117; UDI/DI N/A, System ID 727581INF, Serial Number 17787; UDI/DI N/A, System ID 954735INF2, Serial Number 16920; UDI/DI N/A, System ID 954978INF1, Serial Number 18030; UDI/DI N/A, System ID 305325INF, Serial Number 16792; UDI/DI N/A, System ID 239NCHINF1, Serial Number 17968; UDI/DI N/A, System ID 904276INF1, Serial Number 18228; UDI/DI N/A, System ID 941235INF, Serial Number 16305; UDI/DI N/A, System ID 941766INF2, Serial Number 16326; UDI/DI N/A, System ID 941637INF, Serial Number 16045; UDI/DI N/A, System ID 904819INF1, Serial Number 16660; UDI/DI N/A, System ID 727521INF, Serial Number 17564; UDI/DI N/A, System ID CFRHINF, Serial Number 17992; UDI/DI N/A, System ID 813870INF, Serial Number 16783; UDI/DI N/A, System ID 727942INF, Serial Number 17144; UDI/DI N/A, System ID 727843INF1, Serial Number 18231; UDI/DI N/A, System ID 941VRMCINF, Serial Number 17864; UDI/DI N/A, System ID 386362INF1, Serial Number 18336; UDI/DI N/A, System ID 561650INF1, Serial Number 16964; UDI/DI N/A, System ID 229SUMINF, Serial Number 18254; UDI/DI N/A, System ID 404712INF, Serial Number 16262; UDI/DI N/A, System ID 404265INF, Serial Number 16969; UDI/DI N/A, System ID 404686INF, Serial Number 17186; UDI/DI N/A, System ID 706733INF, Serial Number 17402; UDI/DI N/A, System ID 770382INM, Serial Number 16656; UDI/DI N/A, System ID 706278INF, Serial Number 17947; UDI/DI N/A, System ID 770535INF1, Serial Number 17246; UDI/DI N/A, System ID 770219INF, Serial Number 17558; UDI/DI N/A, System ID 478633INFINIA, Serial Number 16768; UDI/DI N/A, System ID 478454INF, Serial Number 18059; UDI/DI N/A, System ID 912486EGNC, Serial Number 16767; UDI/DI N/A, System ID 229259INF, Serial Number 16662; UDI/DI N/A, System ID 229333ICINF1, Serial Number 18146; UDI/DI N/A, System ID 229333ICINF2, Serial Number 18163; UDI/DI N/A, System ID 319272INF, Serial Number 18119; UDI/DI N/A, System ID 630312INF, Serial Number 17119; UDI/DI N/A, System ID 773665INF2, Serial Number 16415; UDI/DI N/A, System ID 773665INF1, Serial Number 16418; UDI/DI N/A, System ID 773884INF, Serial Number 17305; UDI/DI N/A, System ID 773947INF, Serial Number 17554; UDI/DI N/A, System ID 773995INF, Serial Number 17866; UDI/DI N/A, System ID 815756INF, Serial Number 17218; UDI/DI N/A, System ID 630275INF, Serial Number 16542; UDI/DI N/A, System ID 630275INF2, Serial Number 18260; UDI/DI N/A, System ID 217347INFINIA, Serial Number 16770; UDI/DI N/A, System ID 217347INF2, Serial Number 17851; UDI/DI N/A, System ID 630545INF, Serial Number 16553; UDI/DI N/A, System ID 618942INF, Serial Number 17826; UDI/DI N/A, System ID 847480INF, Serial Number 17443; UDI/DI N/A, System ID 630856INF, Serial Number 16470; UDI/DI N/A, System ID 815432INF, Serial Number 17806; UDI/DI N/A, System ID 847990INF1, Serial Number 18066; UDI/DI N/A, System ID 618993INF, Serial Number 17239; UDI/DI N/A, System ID 708684INF1, Serial Number 17769; UDI/DI N/A, System ID 708660INF, Serial Number 17969; UDI/DI N/A, System ID 618234INF1, Serial Number 17516; UDI/DI N/A, System ID 618395INF, Serial Number 17676; UDI/DI N/A, System ID 708747INFACQ, Serial Number 16319; UDI/DI N/A, System ID 618544INF, Serial Number 17201; UDI/DI N/A, System ID 630786INF, Serial Number 17815; UDI/DI N/A, System ID 217544NUC1, Serial Number 16937; UDI/DI N/A, System ID 815432INFINIA, Serial Number 17403; UDI/DI N/A, System ID 309655INF1, Serial Number 16991; UDI/DI N/A, System ID 309344SMNUC, Serial Number 16923; UDI/DI N/A, System ID 815395INF, Serial Number 18164; UDI/DI N/A, System ID 618256INF1, Serial Number 17790; UDI/DI N/A, System ID 765552INF, Serial Number 17748; UDI/DI N/A, System ID 317415INF, Serial Number 18145; UDI/DI N/A, System ID 812842INF1, Serial Number 16628; UDI/DI N/A, System ID 812522INF, Serial Number 16411; UDI/DI N/A, System ID 620225WPI, Serial Number 17073; UDI/DI N/A, System ID 913588INF1, Serial Number 17991; UDI/DI N/A, System ID 913541INF1, Serial Number 17235; UDI/DI N/A, System ID 913345INF1, Serial Number 17240; UDI/DI N/A, System ID 316858GI, Serial Number 17216; UDI/DI N/A, System ID 316268VCFI2, Serial Number 17367; UDI/DI N/A, System ID 502350INF, Serial Number 17698; UDI/DI N/A, System ID 502868INF1, Serial Number 16303; UDI/DI N/A, System ID 859313INF, Serial Number 17468; UDI/DI N/A, System ID 859268INF1, Serial Number 17872; UDI/DI N/A, System ID 606878INF2, Serial Number 17941; UDI/DI N/A, System ID 502259INF, Serial Number 16477; UDI/DI N/A, System ID 502893INF, Serial Number 16621; UDI/DI N/A, System ID 859498INF1, Serial Number 18160; UDI/DI N/A, System ID 225381INF, Serial Number 16528; UDI/DI N/A, System ID 504826INF, Serial Number 18446; UDI/DI N/A, System ID 225647INF, Serial Number 17129; UDI/DI N/A, System ID 985230INF, Serial Number 17524; UDI/DI N/A, System ID 225NOINF, Serial Number 18088; UDI/DI N/A, System ID 504873INF2, Serial Number 16475; UDI/DI N/A, System ID 504873INF2, Serial Number 17397; UDI/DI N/A, System ID 337981INF, Serial Number 16634; UDI/DI N/A, System ID 337436INF, Serial Number 16772; UDI/DI N/A, System ID 985785INF, Serial Number 17006; UDI/DI N/A, System ID 225INFINIA, Serial Number 16683; UDI/DI N/A, System ID 225INFINIA, Serial Number 16814; UDI/DI N/A, System ID 504454INF, Serial Number 17862; UDI/DI N/A, System ID 318388INF1, Serial Number 17311; UDI/DI N/A, System ID 318327INF1, Serial Number 17315; UDI/DI N/A, System ID 318330INF1, Serial Number 17364; UDI/DI N/A, System ID 337943INF, Serial Number 17142; UDI/DI N/A, System ID 504537INF, Serial Number 17878; UDI/DI N/A, System ID 318681INFINIA2, Serial Number 17012; UDI/DI N/A, System ID 318798INFINIA, Serial Number 18165; UDI/DI N/A, System ID 985646INF, Serial Number 16877; UDI/DI N/A, System ID 985649INF1, Serial Number 17883; UDI/DI N/A, System ID 985649INF2, Serial Number 17893; UDI/DI N/A, System ID 225658INF, Serial Number 16984; UDI/DI N/A, System ID 508457INF, Serial Number 18316; UDI/DI N/A, System ID 978521INF, Serial Number 17366; UDI/DI N/A, System ID 781979INF1, Serial Number 16221; UDI/DI N/A, System ID 617243INFINIA, Serial Number 17735; UDI/DI N/A, System ID 774442INF, Serial Number 18015; UDI/DI N/A, System ID RADNETNM1753, Serial Number 17789; UDI/DI N/A, System ID 443481BINF, Serial Number 17971; UDI/DI N/A, System ID 301877INF, Serial Number 16491; UDI/DI N/A, System ID 240566INF, Serial Number 17902; UDI/DI N/A, System ID RADNETNM1754, Serial Number 18063; UDI/DI N/A, System ID 410337INF2, Serial Number 16715; UDI/DI N/A, System ID 410337INF3, Serial Number 16816; UDI/DI N/A, System ID 207795INFINIA, Serial Number 17141; UDI/DI N/A, System ID 313343INF2, Serial Number 17111; UDI/DI N/A, System ID 313343INF4, Serial Number 17552; UDI/DI N/A, System ID 313343INF3, Serial Number 17555; UDI/DI N/A, System ID 248471INF, Serial Number 17970; UDI/DI N/A, System ID 616267INFINIA, Serial Number 17263; UDI/DI N/A, System ID 616267INFINIA, Serial Number 17993; UDI/DI N/A, System ID 906293INF, Serial Number 16408; UDI/DI N/A, System ID 248898INF, Serial Number 16497; UDI/DI N/A, System ID 248898INF2, Serial Number 17454; UDI/DI N/A, System ID 248849INF1, Serial Number 17177; UDI/DI N/A, System ID 248849INF2, Serial Number 17253; UDI/DI N/A, System ID 734671INF, Serial Number 16672; UDI/DI N/A, System ID 734467INF, Serial Number 16667; UDI/DI N/A, System ID 218847INF, Serial Number 18298; UDI/DI N/A, System ID 816348INF1, Serial Number 17553; UDI/DI N/A, System ID 816380CASSINF, Serial Number 17753; UDI/DI N/A, System ID 816836CIIN, Serial Number 16988; UDI/DI N/A, System ID 816404INF1, Serial Number 17303; UDI/DI N/A, System ID 573686INF1, Serial Number 16285; UDI/DI N/A, System ID 573686INF2, Serial Number 18173; UDI/DI N/A, System ID CSNMINFINIA, Serial Number 18299; UDI/DI N/A, System ID 662256INFINIA, Serial Number 17451; UDI/DI N/A, System ID 228436INF, Serial Number 16413; UDI/DI N/A, System ID 228523HWK2, Serial Number 18480; UDI/DI N/A, System ID 662244INFINIA, Serial Number 17314; UDI/DI N/A, System ID 601936INF1, Serial Number 16442; UDI/DI N/A, System ID 662423INFINIA, Serial Number 17224; UDI/DI N/A, System ID 601978INF, Serial Number 16234; UDI/DI N/A, System ID 601376INF1, Serial Number 16259; UDI/DI N/A, System ID 601443INF1, Serial Number 16972; UDI/DI N/A, System ID 228818INF, Serial Number 17146; UDI/DI N/A, System ID 662772INFRM1, Serial Number 17036; UDI/DI N/A, System ID 662772INFRM2, Serial Number 17045; UDI/DI N/A, System ID 662772INFRM4, Serial Number 17059; UDI/DI N/A, System ID 406228FINF, Serial Number 18256; UDI/DI N/A, System ID 406731INF1, Serial Number 17823; UDI/DI N/A, System ID BCHINF1, Serial Number 18142; UDI/DI N/A, System ID 828262INFINIA, Serial Number 17948; UDI/DI N/A, System ID 828883INFINIA, Serial Number 17321; UDI/DI N/A, System ID 704384INFI5, Serial Number 16659; UDI/DI N/A, System ID 704316INFI, Serial Number 16971; UDI/DI N/A, System ID 704355INF2, Serial Number 17901; UDI/DI N/A, System ID 704355INF1, Serial Number 17913; UDI/DI N/A, System ID 704863INF1, Serial Number 17965; UDI/DI N/A, System ID 704446INF1, Serial Number 18284; UDI/DI N/A, System ID 704304INF1, Serial Number 18292; UDI/DI N/A, System ID 704304INF2, Serial Number 18339; UDI/DI N/A, System ID 704667INF1, Serial Number 18377; UDI/DI N/A, System ID 704783INFI2, Serial Number 16194; UDI/DI N/A, System ID 704783INFI1, Serial Number 16196; UDI/DI N/A, System ID 919684INF3, Serial Number 17441; UDI/DI N/A, System ID 910323INF1, Serial Number 18240; UDI/DI N/A, System ID PITTINF4, Serial Number 16661; UDI/DI N/A, System ID PITTINF5, Serial Number 16696; UDI/DI N/A, System ID 252436INF1, Serial Number 16382; UDI/DI N/A, System ID 704739INFI, Serial Number 16560; UDI/DI N/A, System ID 980212INF1, Serial Number 18243; UDI/DI N/A, System ID 704225INF1, Serial Number 18115; UDI/DI N/A, System ID 704225INF2, Serial Number 18192; UDI/DI N/A, System ID CRAVENINF1, Serial Number 16812; UDI/DI N/A, System ID CRAVENINF2, Serial Number 17223; UDI/DI N/A, System ID 919781NUCGS, Serial Number 17525; UDI/DI N/A, System ID NASHNM2, Serial Number 17780; UDI/DI N/A, System ID 704487INFINIA1, Serial Number 16646; UDI/DI N/A, System ID 828766INFINIA, Serial Number 17972; UDI/DI N/A, System ID 828586INFINIA, Serial Number 16761; UDI/DI N/A, System ID 701364INF, Serial Number 17521; UDI/DI N/A, System ID 701952NM, Serial Number 17162; UDI/DI N/A, System ID 701774NM, Serial Number 17908; UDI/DI N/A, System ID 402354INF, Serial Number 16866; UDI/DI N/A, System ID 603924INF, Serial Number 17632; UDI/DI N/A, System ID 732840INFINIA, Serial Number 17040; UDI/DI N/A, System ID 856363INFINIA, Serial Number 17551; UDI/DI N/A, System ID 732923INFINIA, Serial Number 18354; UDI/DI N/A, System ID 732292INFINIA, Serial Number 16489; UDI/DI N/A, System ID 973877INFINIA, Serial Number 17304; UDI/DI N/A, System ID 609730INF1, Serial Number 18229; UDI/DI N/A, System ID 609730INF2, Serial Number 18244; UDI/DI N/A, System ID 609652INF, Serial Number 18268; UDI/DI N/A, System ID 973831INFINIA, Serial Number 18120; UDI/DI N/A, System ID 732530INFINIA, Serial Number 16819; UDI/DI N/A, System ID 732530INFINIA2, Serial Number 18345; UDI/DI N/A, System ID 732530INFINIA2, Serial Number 18633; UDI/DI N/A, System ID 908522INFINIA2, Serial Number 16677; UDI/DI N/A, System ID 908522INFINIA3, Serial Number 17489; UDI/DI N/A, System ID 856247INF, Serial Number 18148; UDI/DI N/A, System ID 609835INFINIA, Serial Number 17556; UDI/DI N/A, System ID 702564NUC, Serial Number 17614; UDI/DI N/A, System ID 702853NM, Serial Number 18297; UDI/DI N/A, System ID 607762INF, Serial Number 17744; UDI/DI N/A, System ID 718518INF1, Serial Number 18335; UDI/DI N/A, System ID 718240INF1, Serial Number 17307; UDI/DI N/A, System ID 718240INF2, Serial Number 18002; UDI/DI N/A, System ID 716631NUC, Serial Number 17630; UDI/DI N/A, System ID 607756INF, Serial Number 16695; UDI/DI N/A, System ID 607756INF2, Serial Number 17229; UDI/DI N/A, System ID 607737INF, Serial Number 16425; UDI/DI N/A, System ID 518773INF, Serial Number 17302; UDI/DI N/A, System ID ORMCINFINIA2, Serial Number 18125; UDI/DI N/A, System ID 212562INF1, Serial Number 18251; UDI/DI N/A, System ID 518562INF, Serial Number 17189; UDI/DI N/A, System ID 718948INF, Serial Number 16965; UDI/DI N/A, System ID 845987INFINIA, Serial Number 16322; UDI/DI N/A, System ID 845783ORA01, Serial Number 16457; UDI/DI N/A, System ID 330344INFINIA1, Serial Number 17134; UDI/DI N/A, System ID 419483NUC2, Serial Number 16356; UDI/DI N/A, System ID 740623INFINIA, Serial Number 17653; UDI/DI N/A, System ID 740922INFINIA, Serial Number 18267; UDI/DI N/A, System ID 330343INFINIA, Serial Number 18211; UDI/DI N/A, System ID 513454INF1, Serial Number 16710; UDI/DI N/A, System ID 513867INF, Serial Number 16929; UDI/DI N/A, System ID 937393INF, Serial Number 18452; UDI/DI N/A, System ID 937386INF, Serial Number 18258; UDI/DI N/A, System ID 740264INF3, Serial Number 18324; UDI/DI N/A, System ID 419455INF1, Serial Number 17438; UDI/DI N/A, System ID 937440INF2, Serial Number 17687; UDI/DI N/A, System ID 419933I1, Serial Number 18358; UDI/DI N/A, System ID 740356INF1, Serial Number 16207; UDI/DI N/A, System ID 740356INF2, Serial Number 16538; UDI/DI N/A, System ID 580931INF1, Serial Number 17212; UDI/DI N/A, System ID 580249IN1, Serial Number 17270; UDI/DI N/A, System ID 405610MINF1, Serial Number 16566; UDI/DI N/A, System ID 405271VAINF1, Serial Number 18279; UDI/DI N/A, System ID 405742INF1, Serial Number 18117; UDI/DI N/A, System ID 918307INF1, Serial Number 17016; UDI/DI N/A, System ID 918294INF1, Serial Number 17081; UDI/DI N/A, System ID 918494INF2, Serial Number 17211; UDI/DI N/A, System ID 918477INF1, Serial Number 17329; UDI/DI N/A, System ID 918502INF1, Serial Number 18222; UDI/DI N/A, System ID 918494INF3, Serial Number 18225; UDI/DI N/A, System ID 918505INF1, Serial Number 18511; UDI/DI N/A, System ID 610770INFINIA, Serial Number 16426; UDI/DI N/A, System ID 610402INFINIA, Serial Number 16751; UDI/DI N/A, System ID 814452INF1, Serial Number 17762; UDI/DI N/A, System ID 814643INF, Serial Number 18067; UDI/DI N/A, System ID 717544INFINIA, Serial Number 16229; UDI/DI N/A, System ID 814333INFINIA1, Serial Number 18201; UDI/DI N/A, System ID 814333INFINIA2, Serial Number 18212; UDI/DI N/A, System ID 724226INF1, Serial Number 17334; UDI/DI N/A, System ID 215537INFINIA, Serial Number 16557; UDI/DI N/A, System ID 412343INF1, Serial Number 17444; UDI/DI N/A, System ID 610327INFINIA, Serial Number 18097; UDI/DI N/A, System ID 570836INFINIA, Serial Number 16864; UDI/DI N/A, System ID 814723INF, Serial Number 16665; UDI/DI N/A, System ID 814467INF, Serial Number 17563; UDI/DI N/A, System ID 843724INF, Serial Number 16212; UDI/DI N/A, System ID 843724INF2, Serial Number 16466; UDI/DI N/A, System ID 843402INF, Serial Number 17519; UDI/DI N/A, System ID 843402INF2, Serial Number 17802; UDI/DI N/A, System ID 843797INF1, Serial Number 18432; UDI/DI N/A, System ID 843674IN1, Serial Number 17168; UDI/DI N/A, System ID 843674IN2, Serial Number 17296; UDI/DI N/A, System ID 843674IN3, Serial Number 17313; UDI/DI N/A, System ID 843777IN1, Serial Number 17958; UDI/DI N/A, System ID 843777IN2, Serial Number 17981; UDI/DI N/A, System ID 843777IN3, Serial Number 18481; UDI/DI N/A, System ID 864675INFI, Serial Number 17413; UDI/DI N/A, System ID 843689INF, Serial Number 16993; UDI/DI N/A, System ID 843412INF, Serial Number 17781; UDI/DI N/A, System ID 843606INF1, Serial Number 17899; UDI/DI N/A, System ID 843692IN1, Serial Number 18029; UDI/DI N/A, System ID 803329INFIN1, Serial Number 17283; UDI/DI N/A, System ID 885INFI2, Serial Number 18104; UDI/DI N/A, System ID 843832INF, Serial Number 17188; UDI/DI N/A, System ID 843782INF, Serial Number 17996; UDI/DI N/A, System ID 605333INF2, Serial Number 17273; UDI/DI N/A, System ID 605353NM, Serial Number 16861; UDI/DI N/A, System ID 605333INF3, Serial Number 18317; UDI/DI N/A, System ID 605333INF4, Serial Number 18318; UDI/DI N/A, System ID 605333INF5, Serial Number 18322; UDI/DI N/A, System ID 423493PINF, Serial Number 16806; UDI/DI N/A, System ID 931381NM2, Serial Number 17184; UDI/DI N/A, System ID 615328NM1, Serial Number 17401; UDI/DI N/A, System ID 731425NMIC1, Serial Number 16279; UDI/DI N/A, System ID 731425NMRM, Serial Number 16323; UDI/DI N/A, System ID 865373INF, Serial Number 17785; UDI/DI N/A, System ID 865977INF, Serial Number 16673; UDI/DI N/A, System ID 901495INFHAWK, Serial Number 16428; UDI/DI N/A, System ID 901765INFRM8, Serial Number 16935; UDI/DI N/A, System ID 901287INF1, Serial Number 17944; UDI/DI N/A, System ID 615349NM2, Serial Number 17980; UDI/DI N/A, System ID 615349NM1, Serial Number 17988; UDI/DI N/A, System ID 615284INF1, Serial Number 16465; UDI/DI N/A, System ID 615342INF1, Serial Number 16499; UDI/DI N/A, System ID 615781NM1, Serial Number 18220; UDI/DI N/A, System ID 423625INFINIA, Serial Number 17471; UDI/DI N/A, System ID 731644INF, Serial Number 17834; UDI/DI N/A, System ID 865947INFINIA1, Serial Number 16208; UDI/DI N/A, System ID 865545INFINIA1, Serial Number 16235; UDI/DI N/A, System ID 865429INFINIA, Serial Number 17803; UDI/DI N/A, System ID 931967NM, Serial Number 17380; UDI/DI N/A, System ID 806354NWINF, Serial Number 17446; UDI/DI N/A, System ID 806354ACINFINIA, Serial Number 18309; UDI/DI N/A, System ID 806354NWINF2, Serial Number 18304; UDI/DI N/A, System ID 817472INF, Serial Number 18203; UDI/DI N/A, System ID 817685INF, Serial Number 17386; UDI/DI N/A, System ID 972394INF, Serial Number 17910; UDI/DI N/A, System ID 512528NM1, Serial Number 17096; UDI/DI N/A, System ID 214820INF1, Serial Number 16227; UDI/DI N/A, System ID 214879INF, Serial Number 16539; UDI/DI N/A, System ID 214324INF, Serial Number 16640; UDI/DI N/A, System ID Not Available, Serial Number 16526; UDI/DI N/A, System ID 479524INF, Serial Number 16649; UDI/DI N/A, System ID 915747NUC, Serial Number 17279; UDI/DI N/A, System ID 915595GNM1, Serial Number 18364; UDI/DI N/A, System ID 940521NM1, Serial Number 17538; UDI/DI N/A, System ID 713785SLINF3, Serial Number 16635; UDI/DI N/A, System ID 713785SLINF2, Serial Number 16658; UDI/DI N/A, System ID 713242INF3, Serial Number 16725; UDI/DI N/A, System ID 281MPINFII, Serial Number 17026; UDI/DI N/A, System ID 713722INF, Serial Number 17371; UDI/DI N/A, System ID 281251SLVINF, Serial Number 18006; UDI/DI N/A, System ID 713794INF3, Serial Number 18027; UDI/DI N/A, System ID 832522INF, Serial Number 18048; UDI/DI N/A, System ID 832522INF2, Serial Number 18052; UDI/DI N/A, System ID 281348INF, Serial Number 18064; UDI/DI N/A, System ID 512324NM, Serial Number 17660; UDI/DI N/A, System ID 361694DNMINF, Serial Number 18450; UDI/DI N/A, System ID 432685DNUC, Serial Number 16312; UDI/DI N/A, System ID Not Available, Serial Number 18622; UDI/DI N/A, System ID 903731INFINIA, Serial Number 16271; UDI/DI N/A, System ID 903785INF, Serial Number 17424; UDI/DI N/A, System ID 713359INF1, Serial Number 16372; UDI/DI N/A, System ID 409985NMI1, Serial Number 16712; UDI/DI N/A, System ID 210617NM1, Serial Number 17712; UDI/DI N/A, System ID 210575INF1, Serial Number 17836; UDI/DI N/A, System ID 210MTINFINIA, Serial Number 18177; UDI/DI N/A, System ID 281637INF, Serial Number 17501; UDI/DI N/A, System ID 281274DINF, Serial Number 18328; UDI/DI N/A, System ID 903885NM, Serial Number 17324; UDI/DI N/A, System ID 325235NUC, Serial Number 18106; UDI/DI N/A, System ID 409938INF, Serial Number 18221; UDI/DI N/A, System ID 817599INF, Serial Number 18248; UDI/DI N/A, System ID 979532INF1, Serial Number 16786; UDI/DI N/A, System ID 972498INF, Serial Number 16263; UDI/DI N/A, System ID 801479INF, Serial Number 16670; UDI/DI N/A, System ID 435658INF, Serial Number 17667; UDI/DI N/A, System ID 703558INF, Serial Number 17192; UDI/DI N/A, System ID 757312INF2, Serial Number 17975; UDI/DI N/A, System ID 757312INF1, Serial Number 18065; UDI/DI N/A, System ID 703391INF1, Serial Number 18321; UDI/DI N/A, System ID 571231INF2, Serial Number 18167; UDI/DI N/A, System ID 540498INF1, Serial Number 17784; UDI/DI N/A, System ID 703858INF, Serial Number 17593; UDI/DI N/A, System ID SLGHINF, Serial Number 17115; UDI/DI N/A, System ID MVINFNM2, Serial Number 17798; UDI/DI N/A, System ID 804594INF1, Serial Number 16456; UDI/DI N/A, System ID 804957INF2, Serial Number 17431; UDI/DI N/A, System ID 804957INF1, Serial Number 17433; UDI/DI N/A, System ID 804254INF, Serial Number 17504; UDI/DI N/A, System ID 804225INF1, Serial Number 17909; UDI/DI N/A, System ID 804281INF1, Serial Number 18138; UDI/DI N/A, System ID LGMCINF, Serial Number 16421; UDI/DI N/A, System ID 509473INFINIA, Serial Number 17483; UDI/DI N/A, System ID 920849INF, Serial Number 18051; UDI/DI N/A, System ID 920907INF, Serial Number 16576; UDI/DI N/A, System ID 262656INF2, Serial Number 17640; UDI/DI N/A, System ID Not Available, Serial Number 17202; UDI/DI N/A, System ID 262687INF2, Serial Number 17957; UDI/DI N/A, System ID 920451INF, Serial Number 17027; UDI/DI N/A, System ID 681342INF1, Serial Number 17877; UDI/DI N/A, System ID 681342INF3, Serial Number 17887; UDI/DI N/A, System ID 681342INF4, Serial Number 17891; UDI/DI N/A, System ID 681342INF2, Serial Number 17894; UDI/DI N/A, System ID 304637INF, Serial Number 17001; UDI/DI N/A, System ID 304831LNM1, Serial Number 17984; UDI/DI N/A, System ID 304257NM, Serial Number 17411; UDI/DI N/A, System ID 307332INFINIA, Serial Number 17964; UDI/DI N/A, System ID DZ1035NM01, Serial Number 16809; UDI/DI N/A, System ID 0910264058, Serial Number 16381; UDI/DI N/A, System ID 0910264098, Serial Number 17432; UDI/DI N/A, System ID 0910265055, Serial Number 16531; UDI/DI N/A, System ID AH3403NU01, Serial Number 17911; UDI/DI N/A, System ID AH5689NU01, Serial Number 16592; UDI/DI N/A, System ID 080053NU02, Serial Number 16882; UDI/DI N/A, System ID 010120NU11, Serial Number 16614; UDI/DI N/A, System ID 080004NU13, Serial Number 16583; UDI/DI N/A, System ID 030037NU04, Serial Number 17436; UDI/DI N/A, System ID 220826NU01, Serial Number 16298; UDI/DI N/A, System ID 030018NU05, Serial Number 16198; UDI/DI N/A, System ID 160150NU04, Serial Number 17527; UDI/DI N/A, System ID 030010NU05, Serial Number 17420; UDI/DI N/A, System ID NM18471, Serial Number 18471; UDI/DI N/A, System ID NM18342, Serial Number 18342; UDI/DI N/A, System ID NM18356, Serial Number 18356; UDI/DI N/A, System ID NM18409, Serial Number 18409; UDI/DI N/A, System ID NM18346, Serial Number 18346; UDI/DI N/A, System ID 1153389, Serial Number 16483; UDI/DI N/A, System ID NM18427, Serial Number 18427; UDI/DI N/A, System ID NM18443, Serial Number 18443; UDI/DI N/A, System ID NM18365, Serial Number 18365; UDI/DI N/A, System ID NMCR-18161, Serial Number 18232; UDI/DI N/A, System ID NM18467, Serial Number 18467; UDI/DI N/A, System ID NMINDTCRL0206, Serial Number 18271; UDI/DI N/A, System ID 2812777, Serial Number 17693; UDI/DI N/A, System ID 2883051, Serial Number 18031; UDI/DI N/A, System ID NMCR-17980, Serial Number 18227; UDI/DI N/A, System ID NM18486, Serial Number 18486; UDI/DI N/A, System ID 1299296, Serial Number 17628; UDI/DI N/A, System ID 2827087, Serial Number 17763; UDI/DI N/A, System ID NMINDTCRL0311, Serial Number 18272; UDI/DI N/A, System ID 403229INFINIA, Serial Number 16766; UDI/DI N/A, System ID 780875INFINIA, Serial Number 18437; UDI/DI N/A, System ID 250754INFINIA, Serial Number 16699; UDI/DI N/A, System ID 250754INFINIA2, Serial Number 16716; UDI/DI N/A, System ID 604520INFINIA1, Serial Number 16190; UDI/DI N/A, System ID 604520INFINIA1, Serial Number 16206; UDI/DI N/A, System ID 604520INFINIA2, Serial Number 16250; UDI/DI N/A, System ID 604588INFINIA1, Serial Number 16224; UDI/DI N/A, System ID 604875INFINIA1, Serial Number 16094; UDI/DI N/A, System ID 514842AINFINIA, Serial Number 16639; UDI/DI N/A, System ID 204787INFINIA, Serial Number 16645; UDI/DI N/A, System ID 709737INFINIA, Serial Number 16750; UDI/DI N/A, System ID 905683IN1, Serial Number 17936; UDI/DI N/A, System ID 905522INFINIA, Serial Number 16469; UDI/DI N/A, System ID 905522INFINIA2, Serial Number 17009; UDI/DI N/A, System ID 519965INFINIA, Serial Number 16587; UDI/DI N/A, System ID 905472INHE4A, Serial Number 17132; UDI/DI N/A, System ID 905848INFINIA, Serial Number 16736; UDI/DI N/A, System ID 613727INFIN, Serial Number 16733; UDI/DI N/A, System ID 905358INFINIA, Serial Number 16719; UDI/DI N/A, System ID 905773INFINIA1, Serial Number 16434; UDI/DI N/A, System ID 519631INFINIA, Serial Number 16220; UDI/DI N/A, System ID 705674INFINIA, Serial Number 16313; UDI/DI N/A, System ID 416928INFINIA, Serial Number 16626; UDI/DI N/A, System ID 416813INFINIA, Serial Number 16705; UDI/DI N/A, System ID 416469INHE4A, Serial Number 17518; UDI/DI N/A, System ID 905832INFINIA, Serial Number 17642; UDI/DI N/A, System ID 416756INFINIA2, Serial Number 16663; UDI/DI N/A, System ID 905855INFINIA, Serial Number 16324; UDI/DI N/A, System ID 416444INFINIA1, Serial Number 16664; UDI/DI N/A, System ID 905855INFINIA2, Serial Number 18095; UDI/DI N/A, System ID 306655INFINIA2, Serial Number 16608; UDI/DI N/A, System ID 306655INFINIA4, Serial Number 17196; UDI/DI N/A, System ID 905855INFINIA3, Serial Number 18083; UDI/DI N/A, System ID 82426110010, Serial Number 18281; UDI/DI N/A, System ID 082426040045, Serial Number 18349; UDI/DI N/A, System ID 082426110007, Serial Number 17919; UDI/DI N/A, System ID 082426190025, Serial Number 18507; UDI/DI N/A, System ID 082426220008, Serial Number 18527; UDI/DI N/A, System ID 082426140021, Serial Number 18033; UDI/DI N/A, System ID 082426230023, Serial Number 18552; UDI/DI N/A, System ID 082426120017, Serial Number 17713; UDI/DI N/A, System ID 082426140026, Serial Number 18557; UDI/DI N/A, System ID 082426150025, Serial Number 18525; UDI/DI N/A, System ID 082426130031, Serial Number 18310; UDI/DI N/A, System ID 082426160036, Serial Number 18436; UDI/DI N/A, System ID 082426310027, Serial Number 18654; UDI/DI N/A, System ID 082426070022, Serial Number 17777; UDI/DI N/A, System ID 082426100050, Serial Number 18500; UDI/DI N/A, System ID 082426240006, Serial Number 18631; UDI/DI N/A, System ID 082426150022, Serial Number 17822; UDI/DI N/A, System ID 082426150034, Serial Number 18414; UDI/DI N/A, System ID 082426150029, Serial Number 18453; UDI/DI N/A, System ID 082426160045, Serial Number 18632; UDI/DI N/A, System ID 082426240003, Serial Number 18206; UDI/DI N/A, System ID 082426070033, Serial Number 18498; UDI/DI N/A, System ID 082426010015, Serial Number 18458; UDI/DI N/A, System ID 082426210021, Serial Number 18521; UDI/DI N/A, System ID 082426190029, Serial Number 18634; UDI/DI N/A, System ID 082426200008, Serial Number 18331; UDI/DI N/A, System ID 082426030025, Serial Number 18558; UDI/DI N/A, System ID 082426100044, Serial Number 18263; UDI/DI N/A, System ID 082426100065, Serial Number 18630; UDI/DI N/A, System ID 82426100073, Serial Number 18519; UDI/DI N/A, System ID 082426130025, Serial Number 16857; UDI/DI N/A, System ID 082426070036, Serial Number 18607; UDI/DI N/A, System ID 082426050010, Serial Number 18608; UDI/DI N/A, System ID 082426270005, Serial Number 16191; UDI/DI N/A, System ID 082426270006, Serial Number 17951; UDI/DI N/A, System ID 082426270008, Serial Number 18424; UDI/DI N/A, System ID 082426140017, Serial Number 17261; UDI/DI N/A, System ID NM18451, Serial Number 18451; UDI/DI N/A, System ID NMINDTCRL0351, Serial Number 18270; UDI/DI N/A, System ID 2928217INF, Serial Number 18216; UDI/DI N/A, System ID 2583615INF, Serial Number 16513; UDI/DI N/A, System ID NM18363, Serial Number 18363; UDI/DI N/A, System ID HR4103NM01, Serial Number 18237; UDI/DI N/A, System ID 18076INFINIA, Serial Number 18076; UDI/DI N/A, System ID NM17487 , Serial Number 17487; UDI/DI N/A, System ID EG1538MN01, Serial Number 16940; UDI/DI N/A, System ID M4159227, Serial Number 16376; UDI/DI N/A, System ID B5483443, Serial Number 17912; UDI/DI N/A, System ID M4163763, Serial Number 16841; UDI/DI N/A, System ID M4480232, Serial Number 17066; UDI/DI N/A, System ID M44827146, Serial Number 17332; UDI/DI N/A, System ID E4858901, Serial Number 17327; UDI/DI N/A, System ID X4211026, Serial Number 16704; UDI/DI N/A, System ID M4018536, Serial Number 17421; UDI/DI N/A, System ID X100611101, Serial Number 16447; UDI/DI N/A, System ID M4144332, Serial Number 16748; UDI/DI N/A, System ID Not Available, Serial Number 16788; UDI/DI N/A, System ID HC0507NU03, Serial Number 17925; UDI/DI N/A, System ID PC3906NU02, Serial Number 18369; UDI/DI N/A, System ID UC7655NU03, Serial Number 17355; UDI/DI N/A, System ID 783867NU01, Serial Number 16419; UDI/DI N/A, System ID PC8118NU01, Serial Number 17093; UDI/DI N/A, System ID HC7475NU03, Serial Number 17160; UDI/DI N/A, System ID HC4014NU01, Serial Number 17465; UDI/DI N/A, System ID UC4109NU02, Serial Number 18341; UDI/DI N/A, System ID PC1961NU02, Serial Number 18397; UDI/DI N/A, System ID PM1633NU03, Serial Number 18401; UDI/DI N/A, System ID HC1819NU01, Serial Number 17592; UDI/DI N/A, System ID HC2252NU01, Serial Number 18253; UDI/DI N/A, System ID HC3442NU01, Serial Number 18070; UDI/DI N/A, System ID PC1818NU03, Serial Number 17365; UDI/DI N/A, System ID 493519NU01, Serial Number 18078; UDI/DI N/A, System ID PC7590NU02, Serial Number 17863; UDI/DI N/A, System ID HC1249NU02, Serial Number 17874; UDI/DI N/A, System ID H2193NUC13, Serial Number 18379; UDI/DI N/A, System ID H6892NUC03, Serial Number 17818; UDI/DI N/A, System ID HU1099NM01, Serial Number 16908; UDI/DI N/A, System ID 83026103634616, Serial Number 16837; UDI/DI N/A, System ID 083026002002289, Serial Number 17832; UDI/DI N/A, System ID 083026242101977, Serial Number 17076; UDI/DI N/A, System ID 083026000016013, Serial Number 18522; UDI/DI N/A, System ID R83026104634524 , Serial Number 18223; UDI/DI N/A, System ID 083026822100376, Serial Number 16823; UDI/DI N/A, System ID 083026862101014, Serial Number 16336; UDI/DI N/A, System ID 083026208377210, Serial Number 17871; UDI/DI N/A, System ID R83026604634824, Serial Number 18136; UDI/DI N/A, System ID 083026802101686, Serial Number 16739; UDI/DI N/A, System ID 083026801003210, Serial Number 17929; UDI/DI N/A, System ID 083026602101279, Serial Number 17816; UDI/DI N/A, System ID 083026602101669, Serial Number 17671; UDI/DI N/A, System ID IE1006MN04, Serial Number 17176; UDI/DI N/A, System ID IE1053MN01, Serial Number 16680; UDI/DI N/A, System ID IL1018NM07, Serial Number 17765; UDI/DI N/A, System ID IL1066NM06, Serial Number 16854; UDI/DI N/A, System ID A51043155, Serial Number 16213; UDI/DI N/A, System ID A51043187, Serial Number 18174; UDI/DI N/A, System ID B5395703, Serial Number 16904; UDI/DI N/A, System ID A5215935, Serial Number 16579; UDI/DI N/A, System ID B5142302, Serial Number 16738; UDI/DI N/A, System ID A5181660, Serial Number 18101; UDI/DI N/A, System ID A5279302, Serial Number 16211; UDI/DI N/A, System ID A186363001, Serial Number 17159; UDI/DI N/A, System ID C5120912, Serial Number 16756; UDI/DI N/A, System ID C5120915, Serial Number 16760; UDI/DI N/A, System ID A5129026, Serial Number 17505; UDI/DI N/A, System ID A156941423, Serial Number 17760; UDI/DI N/A, System ID A5113627, Serial Number 16749; UDI/DI N/A, System ID A5352208, Serial Number 16913; UDI/DI N/A, System ID A5352208, Serial Number 17356; UDI/DI N/A, System ID A58080111, Serial Number 17708; UDI/DI N/A, System ID A58080134, Serial Number 17982; UDI/DI N/A, System ID A5634003, Serial Number 17840; UDI/DI N/A, System ID A5178021, Serial Number 17604; UDI/DI N/A, System ID A5315551, Serial Number 16509; UDI/DI N/A, System ID A5111240, Serial Number 17095; UDI/DI N/A, System ID A5924402, Serial Number 16776; UDI/DI N/A, System ID A51152164, Serial Number 17560; UDI/DI N/A, System ID A5172907, Serial Number 16135; UDI/DI N/A, System ID A52985, Serial Number 16851; UDI/DI N/A, System ID YN1558, Serial Number 17230; UDI/DI N/A, System ID YN1551, Serial Number 16460; UDI/DI N/A, System ID YN1588, Serial Number 17879; UDI/DI N/A, System ID YN1575, Serial Number 16455; UDI/DI N/A, System ID YN1585, Serial Number 17768; UDI/DI N/A, System ID YN4936, Serial Number 18290; UDI/DI N/A, System ID YN1582, Serial Number 17876; UDI/DI N/A, System ID YN1559, Serial Number 17342; UDI/DI N/A, System ID YN1561, Serial Number 17357; UDI/DI N/A, System ID YN1567, Serial Number 17612; UDI/DI N/A, System ID YN1552, Serial Number 17155; UDI/DI N/A, System ID YN1547, Serial Number 16830; UDI/DI N/A, System ID YN4918, Serial Number 18103; UDI/DI N/A, System ID YN4939, Serial Number 18371; UDI/DI N/A, System ID YN4919, Serial Number 18137; UDI/DI N/A, System ID YN1196, Serial Number 16246; UDI/DI N/A, System ID YN1572, Serial Number 17672; UDI/DI N/A, System ID YN4934, Serial Number 18238; UDI/DI N/A, System ID YN1589, Serial Number 18046; UDI/DI N/A, System ID YN1587, Serial Number 18054; UDI/DI N/A, System ID YN4927, Serial Number 18207; UDI/DI N/A, System ID YN1586, Serial Number 17914; UDI/DI N/A, System ID YN4930, Serial Number 17939; UDI/DI N/A, System ID YN4935, Serial Number 18288; UDI/DI N/A, System ID YN4938, Serial Number 18340; UDI/DI N/A, System ID YN4820, Serial Number 17206; UDI/DI N/A, System ID YN1562, Serial Number 17512; UDI/DI N/A, System ID YN1566, Serial Number 17562; UDI/DI N/A, System ID YN4945, Serial Number 18468; UDI/DI N/A, System ID YN1573, Serial Number 17766; UDI/DI N/A, System ID YN1578, Serial Number 17845; UDI/DI N/A, System ID YN1581, Serial Number 17868; UDI/DI N/A, System ID YN1584, Serial Number 17886; UDI/DI N/A, System ID YN4926, Serial Number 18246; UDI/DI N/A, System ID YN4953, Serial Number 18419; UDI/DI N/A, System ID YN4956, Serial Number 18499; UDI/DI N/A, System ID YN4947, Serial Number 18431; UDI/DI N/A, System ID YN4921, Serial Number 18128; UDI/DI N/A, System ID YN4951, Serial Number 18466; UDI/DI N/A, System ID YN4941, Serial Number 18393; UDI/DI N/A, System ID YN4955, Serial Number 18488; UDI/DI N/A, System ID YN4923, Serial Number 18178; UDI/DI N/A, System ID YN1553, Serial Number 16533; UDI/DI N/A, System ID YN1577, Serial Number 17361; UDI/DI N/A, System ID YN4928, Serial Number 18252; UDI/DI N/A, System ID YN1579, Serial Number 17842; UDI/DI N/A, System ID YN4944, Serial Number 18438; UDI/DI N/A, System ID YN1556, Serial Number 16500; UDI/DI N/A, System ID YN4924, Serial Number 18179; UDI/DI N/A, System ID YN1583, Serial Number 17875; UDI/DI N/A, System ID YN1563, Serial Number 17609; UDI/DI N/A, System ID YN4990, Serial Number 18110; UDI/DI N/A, System ID YN4999, Serial Number 18291; UDI/DI N/A, System ID YN4920, Serial Number 17938; UDI/DI N/A, System ID YN4929, Serial Number 18188; UDI/DI N/A, System ID YN4954, Serial Number 18495; UDI/DI N/A, System ID YN4922, Serial Number 18151; UDI/DI N/A, System ID YN1542, Serial Number 16686; UDI/DI N/A, System ID YN4948, Serial Number 18395; UDI/DI N/A, System ID YN1557, Serial Number 17203; UDI/DI N/A, System ID YN4946, Serial Number 18449; UDI/DI N/A, System ID YN1544, Serial Number 16694; UDI/DI N/A, System ID YN8002, Serial Number 17846; UDI/DI N/A, System ID YN1580, Serial Number 17811; UDI/DI N/A, System ID YN8001, Serial Number 16706; UDI/DI N/A, System ID YN4950, Serial Number 18247; UDI/DI N/A, System ID YN1560, Serial Number 16632; UDI/DI N/A, System ID YN4942, Serial Number 18301; UDI/DI N/A, System ID YN1545, Serial Number 16848; UDI/DI N/A, System ID YN1554, Serial Number 17080; UDI/DI N/A, System ID YN4949, Serial Number 18092; UDI/DI N/A, System ID YN4925, Serial Number 18197; UDI/DI N/A, System ID YN8003, Serial Number 18012; UDI/DI N/A, System ID YN1546, Serial Number 16853; UDI/DI N/A, System ID YN1548, Serial Number 16858; UDI/DI N/A, System ID YN5000, Serial Number 17895; UDI/DI N/A, System ID YN4940, Serial Number 18262; UDI/DI N/A, System ID YN4952, Serial Number 18493; UDI/DI N/A, System ID YN4933, Serial Number 18261; UDI/DI N/A, System ID YN4932, Serial Number 18245; UDI/DI N/A, System ID YN4943, Serial Number 18456; UDI/DI N/A, System ID YN4931, Serial Number 18155; UDI/DI N/A, System ID 850260063, Serial Number 16170; UDI/DI N/A, System ID 0850260076, Serial Number 16636; UDI/DI N/A, System ID 850260080, Serial Number 16779; UDI/DI N/A, System ID 850260084, Serial Number 16870; UDI/DI N/A, System ID 850260100, Serial Number 17375; UDI/DI N/A, System ID 850260112, Serial Number 17771; UDI/DI N/A, System ID 0850260127, Serial Number 18370; UDI/DI N/A, System ID 0850260130, Serial Number 18374; UDI/DI N/A, System ID 0850260087, Serial Number 16916; UDI/DI N/A, System ID 0850260092, Serial Number 16979; UDI/DI N/A, System ID 850260120, Serial Number 18109; UDI/DI N/A, System ID 0850260069, Serial Number 16478; UDI/DI N/A, System ID 0850260129, Serial Number 18275; UDI/DI N/A, System ID 0850260090, Serial Number 16943; UDI/DI N/A, System ID 0850260099, Serial Number 17291; UDI/DI N/A, System ID 850260113, Serial Number 17775; UDI/DI N/A, System ID 0850260103, Serial Number 17472; UDI/DI N/A, System ID 0850260066, Serial Number 16370; UDI/DI N/A, System ID 0850260067, Serial Number 16318; UDI/DI N/A, System ID 0850260068, Serial Number 16404; UDI/DI N/A, System ID 850260064, Serial Number 16216; UDI/DI N/A, System ID 850260079, Serial Number 16747; UDI/DI N/A, System ID 850260061, Serial Number 16115; UDI/DI N/A, System ID 0850260089, Serial Number 16778; UDI/DI N/A, System ID 850260081, Serial Number 16839; UDI/DI N/A, System ID 850260082, Serial Number 16860; UDI/DI N/A, System ID 0850260088, Serial Number 16942; UDI/DI N/A, System ID 0850260094, Serial Number 17008; UDI/DI N/A, System ID 0850260093, Serial Number 17017; UDI/DI N/A, System ID 0850260095, Serial Number 17031; UDI/DI N/A, System ID 0850260104, Serial Number 17498; UDI/DI N/A, System ID 850260107, Serial Number 17644; UDI/DI N/A, System ID 0850260106, Serial Number 17645; UDI/DI N/A, System ID 0850260109, Serial Number 17675; UDI/DI N/A, System ID 0850260110, Serial Number 17683; UDI/DI N/A, System ID 0850260115, Serial Number 17831; UDI/DI N/A, System ID 0850260123, Serial Number 18213; UDI/DI N/A, System ID 0850260114, Serial Number 17791; UDI/DI N/A, System ID KW1013NM01, Serial Number 16781; UDI/DI N/A, System ID KW1018MN06, Serial Number 16948; UDI/DI N/A, System ID KW1013NM02, Serial Number 16784; UDI/DI N/A, System ID KW1005MN11, Serial Number 16794; UDI/DI N/A, System ID KW1018MN05, Serial Number 16793; UDI/DI N/A, System ID 834260012, Serial Number 17945; UDI/DI N/A, System ID 0834260003, Serial Number 16668; UDI/DI N/A, System ID MT1014NM01, Serial Number 16859; UDI/DI N/A, System ID BMALTA02, Serial Number 16304; UDI/DI N/A, System ID NM18510, Serial Number 18510; UDI/DI N/A, System ID NMCR-17849, Serial Number 18176; UDI/DI N/A, System ID 2919654INF, Serial Number 18130; UDI/DI N/A, System ID INF2649553, Serial Number 17078; UDI/DI N/A, System ID NM17434, Serial Number 17434; UDI/DI N/A, System ID NM17378, Serial Number 17378; UDI/DI N/A, System ID NM17898, Serial Number 17898; UDI/DI N/A, System ID 2605823INF, Serial Number 16657; UDI/DI N/A, System ID NM18492, Serial Number 18492; UDI/DI N/A, System ID NA1027NM01, Serial Number 18394; UDI/DI N/A, System ID NO1000MN06, Serial Number 17335; UDI/DI N/A, System ID 4814999A, Serial Number 17888; UDI/DI N/A, System ID PK1001NM01, Serial Number 16939; UDI/DI N/A, System ID 2565059INFINIA, Serial Number 16446; UDI/DI N/A, System ID 0843260044, Serial Number 17242; UDI/DI N/A, System ID PPR12213, Serial Number 16296; UDI/DI N/A, System ID PMR12506, Serial Number 17829; UDI/DI N/A, System ID PPR59030, Serial Number 16902; UDI/DI N/A, System ID RU2311NM01, Serial Number 18378; UDI/DI N/A, System ID RU2311NM02, Serial Number 18383; UDI/DI N/A, System ID RU1021NM02, Serial Number 18384; UDI/DI N/A, System ID RU1095NM02, Serial Number 18385; UDI/DI N/A, System ID RU1212NM01, Serial Number 18407; UDI/DI N/A, System ID RU1109NM01, Serial Number 18405; UDI/DI N/A, System ID RU3521NM01, Serial Number 18408; UDI/DI N/A, System ID RU1091NM01, Serial Number 18403; UDI/DI N/A, System ID RU1302NM01, Serial Number 18406; UDI/DI N/A, System ID ZA1835NM25, Serial Number 16732; UDI/DI N/A, System ID ZA1820NM04, Serial Number 17426; UDI/DI N/A, System ID NPV31728, Serial Number 17281; UDI/DI N/A, System ID MPX82204, Serial Number 17015; UDI/DI N/A, System ID MPX46902, Serial Number 16218; UDI/DI N/A, System ID UPW00402, Serial Number 17782; UDI/DI N/A, System ID UEW19003, Serial Number 17014; UDI/DI N/A, System ID DE539254, Serial Number 16976; UDI/DI N/A, System ID MP842026, Serial Number 16828; UDI/DI N/A, System ID GPQ19105, Serial Number 17924; UDI/DI N/A, System ID A004NU11, Serial Number 16355; UDI/DI N/A, System ID 529150NU04, Serial Number 17565; UDI/DI N/A, System ID 0853260118, Serial Number 18496; UDI/DI N/A, System ID 0853260062, Serial Number 17812; UDI/DI N/A, System ID 0853260074, Serial Number 18091; UDI/DI N/A, System ID 0853260039, Serial Number 17271; UDI/DI N/A, System ID 0853260087, Serial Number 18150; UDI/DI N/A, System ID 0853260046, Serial Number 17167; UDI/DI N/A, System ID 0853260124, Serial Number 18517; UDI/DI N/A, System ID 0853260056, Serial Number 17548; UDI/DI N/A, System ID 0853260072, Serial Number 18025; UDI/DI N/A, System ID 0853260045, Serial Number 17175; UDI/DI N/A, System ID 0853260119, Serial Number 18529; UDI/DI N/A, System ID 0853260113, Serial Number 18514; UDI/DI N/A, System ID 0856260031, Serial Number 18089; UDI/DI N/A, System ID 0856260026, Serial Number 17256; UDI/DI N/A, System ID 0856260028, Serial Number 17673; UDI/DI N/A, System ID 01002NUC04, Serial Number 16334; UDI/DI N/A, System ID 01012NUC01, Serial Number 16896; UDI/DI N/A, System ID 02007NUC01, Serial Number 17694; UDI/DI N/A, System ID 34094NUC02, Serial Number 17855; UDI/DI N/A, System ID 06007NUC21, Serial Number 17857; UDI/DI N/A, System ID 14002NUC01, Serial Number 17856; UDI/DI N/A, System ID 17005NUC01, Serial Number 17808; UDI/DI N/A, System ID 23003NUC01, Serial Number 17257; UDI/DI N/A, System ID 07035NUC01, Serial Number 17427; UDI/DI N/A, System ID 34443NUC02, Serial Number 17428; UDI/DI N/A, System ID 34021NUC02, Serial Number 17849; UDI/DI N/A, System ID 34017NUC01, Serial Number 17854; UDI/DI N/A, System ID 34284NUC04, Serial Number 17860; UDI/DI N/A, System ID 34340NUC01, Serial Number 18242; UDI/DI N/A, System ID 34006NUC03, Serial Number 18389; UDI/DI N/A, System ID 38001NUC01, Serial Number 17591; UDI/DI N/A, System ID 00013NUC01, Serial Number 17794; UDI/DI N/A, System ID 52006NUC01, Serial Number 17523; UDI/DI N/A, System ID 63009NUC01, Serial Number 17859; UDI/DI N/A, System ID 06051NUC01, Serial Number 16214; UDI/DI N/A, System ID 06049NUC04, Serial Number 16504; UDI/DI N/A, System ID 06008NUC09, Serial Number 17610; UDI/DI N/A, System ID 23002NUC01, Serial Number 16941; UDI/DI N/A, System ID 34270NUC02, Serial Number 17861; UDI/DI N/A, System ID 35003NUC04, Serial Number 17274; UDI/DI N/A, System ID 41009NUC01, Serial Number 16960; UDI/DI N/A, System ID 45011NUC01, Serial Number 17843; UDI/DI N/A, System ID UK5002NM01, Serial Number 18036; UDI/DI N/A, System ID 00065NUC05, Serial Number 17153; UDI/DI N/A, System ID 00289NUC02, Serial Number 16775; UDI/DI N/A, System ID 00165NUC04, Serial Number 17123; UDI/DI N/A, System ID 00136NUC03, Serial Number 17069; UDI/DI N/A, System ID 00624NUC03, Serial Number 17952; UDI/DI N/A, System ID 00116NUC01, Serial Number 16720; UDI/DI N/A, System ID 00169NUC07, Serial Number 16310; UDI/DI N/A, System ID 00669NUC01, Serial Number 16371; UDI/DI N/A, System ID NM18612, Serial Number 18612; UDI/DI N/A, System ID 3882942310MNCTR, Serial Number 18209; UDI/DI N/A, System ID 0859260009, Serial Number 18295; UDI/DI N/A, System ID 5973MI0003, Serial Number 18640; UDI/DI N/A, System ID 5973MI0002, Serial Number 18617; UDI/DI N/A, System ID 0859260014, Serial Number 18601; UDI/DI N/A, System ID 0859260012, Serial Number 18562; UDI/DI N/A, System ID 0859260010, Serial Number 18461. |
Recalling Firm/ Manufacturer |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel
|
For Additional Information Contact | GE HealthCare Service 800-437-1171 |
Manufacturer Reason for Recall | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. |
FDA Determined Cause 2 | Package design/selection |
Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/18/2024. The notice explained the safety issue and requested the following actions be taken:
There are two populations potentially affected by this notification:
NOTE: Specific serial numbers of the following affected systems: Infinia Nuclear Medicine Systems: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4; VG Nuclear Medicine systems: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH; Brivo NM 615; Discovery NM 630; Discovery NM/CT 670, Discovery NM/CT 670 ES, Discovery NM/CT 670 DR, Discovery NM/CT 670 PRO, Discovery NM/CT 670 CZT; Optima NM/CT 640.
For Serial Numbers listed in Appendix A of this letter:
GE HealthCare requests that you STOP USING the system until GE HealthCare has inspected and if necessary, corrected your system and provided you with a letter indicating the system can be returned to clinical use. GE HealthCare has determined that these systems could have previously been transported or relocated without proper detector support.
For Serial Numbers listed in Appendix B of this letter:
You can continue to use your system, as GE HealthCare has determined that these systems have not previously been transported or relocated without proper detector support.
For Serial Numbers listed in either Appendix A or Appendix B of this letter:
GE HealthCare requests that you DO NOT physically relocate or transport your system from its current location. If you need to move or transport your system, please email GE HealthCare at recall.40910@gehealthcare.com to receive specific instructions to follow before moving the system. When emailing this address, please provide the following information:
" System serial number
" Current system location
" The reason for the move or transport, and subsequent destination
Do not proceed with a physical relocation or transport of your system until you have received these instructions and taken the actions descri |
Quantity in Commerce | 877 units |
Distribution | Worldwide |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = KPS
|
|
|
|