| | Class 2 Device Recall GE Healthcare Discovery |  |
| Date Initiated by Firm | December 18, 2024 |
| Date Posted | January 10, 2025 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0891-2025 |
| Recall Event ID |
96079 |
| 510(K)Number | K093514 |
| Product Classification |
System, tomography, computed, emission - Product Code KPS
|
| Product | GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers:
1) 5376204-70-54-2,
2) H2401BC,
3) H2401CE,
4) H2401CG,
5) H3100AG,
6) H3100JW,
7) H3100NC; System, Tomography, Computed, Emission |
| Code Information |
1) 5376204-70-54-2: UDI/DI N/A, System ID NT1030, Serial Number T27G16017/ 133897HL9; UDI/DI N/A, System ID NT4004, Serial Number T27G15008/ 128542HL8; UDI/DI N/A, System ID NT4008, Serial Number T27G16019/ 134674HL1; UDI/DI N/A, System ID NT4007, Serial Number T27G16018/ 134286HL4; UDI/DI N/A, System ID NT4009, Serial Number T27G16016/ 133646HL0; UDI/DI N/A, System ID NT1021, Serial Number T27G1700031/ 147750HL4; UDI/DI N/A, System ID NT4010, Serial Number T27G16020/ 134675HL8; UDI/DI N/A, System ID NT4012, Serial Number T27G1700032/ 148489HL8; UDI/DI N/A, System ID NT4001, Serial Number T27G15002/ 122818HL8; UDI/DI N/A, System ID NT4006, Serial Number T27G15013/ 131436HL8; UDI/DI N/A, System ID NT4002, Serial Number T27G15003/ 124423HL5; UDI/DI N/A, System ID NT4013, Serial Number T27G1700035/ 151334HL0.
2) H2401BC: UDI/DI N/A, System ID 83163862277, Serial Number T2EG1700003/153301HL7; UDI/DI N/A, System ID 83103685384, Serial Number T2AG13029/141BH2; UDI/DI N/A, System ID 83095572309, Serial Number T2AG13023/132BH1; UDI/DI N/A, System ID 83095060278, Serial Number T2AG13025/100091HL8; UDI/DI N/A, System ID 83154010867, Serial Number T2EG1600002/0; UDI/DI N/A, System ID 83091096402, Serial Number T2DG13001/133BH9; UDI/DI N/A, System ID 0910265076, Serial Number T2AG12006/86884HL4; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12010/103BH2; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12014/103BH2; UDI/DI N/A, System ID NT1014, Serial Number T2AG13024/134BH7; UDI/DI N/A, System ID KW1001NM01, Serial Number T2BG12002/319938HM7; UDI/DI N/A, System ID 0834260011, Serial Number T2AG13031/106485HL6; UDI/DI N/A, System ID 0920269097, Serial Number T2AG12015/118BH0; UDI/DI N/A, System ID Not Available, Serial Number T2EG15001; UDI/DI N/A, System ID Not Available, Serial Number T2EG1600001; UDI/DI N/A, System ID Not Available, Serial Number T2EG1700004; UDI/DI N/A, System ID Not Available, Serial Number T2AG12007; UDI/DI N/A, System ID Not Available, Serial Number T2AG13019; UDI/DI N/A, System ID Not Available, Serial Number T2AG13021; UDI/DI N/A, System ID Not Available, Serial Number T2AG13026; UDI/DI N/A, System ID Not Available, Serial Number T2DG13002; UDI/DI N/A, System ID Not Available, Serial Number T2BG13004; UDI/DI N/A, System ID Not Available, Serial Number T2DG13003; UDI/DI N/A, System ID Not Available, Serial Number T2AG14034; UDI/DI N/A, System ID Not Available, Serial Number T2BG14005; UDI/DI N/A, System ID Not Available, Serial Number T2EG1700005/153925HL3; UDI/DI N/A, System ID Not Available, Serial Number T2BG12003/92532HL1.
3) H2401CE: UDI/DI N/A, System ID Not Available, Serial Number T2AG15041.
4) H2401CG: UDI/DI N/A, System ID Not Available, Serial Number T25G12006-R1.
5) H3100AG: UDI/DI 840682121187, System ID X129032407, Serial Number DESV28014; UDI/DI 840682121187, System ID A5109138, Serial Number DESV28016; UDI/DI 840682121187, System ID A5109139, Serial Number DESV28017; UDI/DI 840682121187, System ID A51273184, Serial Number DESW28028; UDI/DI N/A , System ID Not Available, Serial Number DESW28025; UDI/DI N/A , System ID 403777D670B, Serial Number DESV28022; UDI/DI N/A , System ID 403777D670A, Serial Number DESV28021; UDI/DI N/A , System ID 250862D670, Serial Number 28005; UDI/DI N/A , System ID 250862D670, Serial Number 28008; UDI/DI N/A , System ID 514890D670A, Serial Number DESV28013; UDI/DI N/A , System ID 082426310032, Serial Number DESX28031; UDI/DI N/A , System ID X6010810, Serial Number 28009; UDI/DI N/A , System ID M4172349, Serial Number DESW28023; UDI/DI N/A , System ID X105967818, Serial Number 28012; UDI/DI N/A , System ID M411063301, Serial Number DESV28018; UDI/DI N/A , System ID M4191125, Serial Number 28006; UDI/DI N/A , System ID 403222NU01, Serial Number 28001; UDI/DI N/A , System ID 141545NU01, Serial Number DESV28020; UDI/DI N/A , System ID A5196352, Serial Number 28007; UDI/DI N/A , System ID HGL02301, Serial Number DESW28029; UDI/DI N/A , System ID MEX70801, Serial Number 28002; UDI/DI N/A , System ID MEX71300, Serial Number 28004; UDI/DI N/A , System ID MEX70607, Serial Number 28003; UDI/DI N/A , System ID 0853260257, Serial Number DESW28027; UDI/DI N/A , System ID 0853260163, Serial Number DESW28026; UDI/DI N/A , System ID 0853260169, Serial Number DESW28030; UDI/DI N/A , System ID 00311NUC07, Serial Number DESV28019; UDI/DI N/A , System ID 207743NM, Serial Number DESW28024; UDI/DI NA, System ID, 514890D670B. Serial Number 28010; UDI/DI NA, System ID 514890D670C, Serial Number 28011.
6) H3100JW: UDI/DI N/A, System ID 250862D670, Serial Number 21383; UDI/DI N/A, System ID 904UFHNDSC2, Serial Number 21324; UDI/DI N/A, System ID 573248D670, Serial Number 21323; UDI/DI N/A, System ID 856355D670, Serial Number 21325; UDI/DI N/A, System ID 605668D670, Serial Number 21373; UDI/DI N/A, System ID 210617670D2, Serial Number 21331; UDI/DI N/A, System ID 210617670D2, Serial Number 21345; UDI/DI N/A, System ID NM21378, Serial Number 21378; UDI/DI N/A, System ID NM21376, Serial Number 21376; UDI/DI N/A, System ID 190205NU08, Serial Number 21355; UDI/DI N/A, System ID NM21351, Serial Number 21351; UDI/DI N/A, System ID NM21339, Serial Number 21339; UDI/DI N/A, System ID 403777D670, Serial Number 21374; UDI/DI N/A, System ID 250862D670, Serial Number 21394; UDI/DI N/A, System ID Not Available, Serial Number 21366; UDI/DI N/A, System ID 902863D670, Serial Number 21368; UDI/DI N/A, System ID 902470D670, Serial Number 21359; UDI/DI N/A, System ID 902567D670, Serial Number 21360; UDI/DI N/A, System ID 902893D670, Serial Number 21386; UDI/DI N/A, System ID 416494D670A, Serial Number 21395; UDI/DI N/A, System ID E416249D670B, Serial Number 21336; UDI/DI N/A, System ID E416249D670B, Serial Number 21338; UDI/DI N/A, System ID 905845D670A, Serial Number 21357; UDI/DI N/A, System ID 905845D670B, Serial Number 21358; UDI/DI N/A, System ID 416534D630, Serial Number 21333; UDI/DI N/A, System ID 082426110014, Serial Number 670W21438; UDI/DI N/A, System ID 082426040073, Serial Number 670V21415; UDI/DI N/A, System ID 082426040064, Serial Number 21367; UDI/DI N/A, System ID 082426040063, Serial Number 21328; UDI/DI N/A, System ID 082426220009, Serial Number 21409; UDI/DI N/A, System ID 082426040065, Serial Number 21346; UDI/DI N/A, System ID 082426040070, Serial Number 21405; UDI/DI N/A, System ID 082426220012, Serial Number 670W21434; UDI/DI N/A, System ID 082426110013, Serial Number 670W21436; UDI/DI N/A, System ID 082426160050, Serial Number 21385; UDI/DI N/A, System ID 082426140034, Serial Number 670V21416; UDI/DI N/A, System ID Not Available, Serial Number 670W21433; UDI/DI N/A, System ID 082426010019, Serial Number 670W21430; UDI/DI N/A, System ID Not Available, Serial Number 670V21423; UDI/DI N/A, System ID 082426130046, Serial Number 21400; UDI/DI N/A, System ID 082426160051, Serial Number 21387; UDI/DI N/A, System ID 082426100068, Serial Number 21398; UDI/DI N/A, System ID 082426100063, Serial Number 21362; UDI/DI N/A, System ID Not Available, Serial Number 670V21426; UDI/DI N/A, System ID Not Available, Serial Number 670V21418; UDI/DI N/A, System ID Not Available, Serial Number 670W21437; UDI/DI N/A, System ID Not Available, Serial Number 670W21429; UDI/DI N/A, System ID 082426150037, Serial Number 21393; UDI/DI N/A, System ID 082426160046, Serial Number 21330; UDI/DI N/A, System ID 082426160049, Serial Number 21361; UDI/DI N/A, System ID 082426160053, Serial Number 21396; UDI/DI N/A, System ID 082426160047, Serial Number 21354; UDI/DI N/A, System ID 082426170005, Serial Number 670W21431; UDI/DI N/A, System ID 082426070043, Serial Number 670V21420; UDI/DI N/A, System ID 082426070040, Serial Number 21365; UDI/DI N/A, System ID 082426010020, Serial Number 670W21428; UDI/DI N/A, System ID 082426010023, Serial Number 670V21417; UDI/DI N/A, System ID 082426010022, Serial Number 21407; UDI/DI N/A, System ID 082426090040, Serial Number 21392; UDI/DI N/A, System ID 082426210027, Serial Number 21399; UDI/DI N/A, System ID 082426210022, Serial Number 21327; UDI/DI N/A, System ID 082426060011, Serial Number 21402; UDI/DI N/A, System ID 082426060013, Serial Number 670V21421; UDI/DI N/A, System ID 082426120027, Serial Number 21408; UDI/DI N/A, System ID 082426120030, Serial Number 21388; UDI/DI N/A, System ID 082426120032, Serial Number 21397; UDI/DI N/A, System ID 082426120038, Serial Number 670W21432; UDI/DI N/A, System ID 082426020010, Serial Number 21363; UDI/DI N/A, System ID 082426020009, Serial Number 21329; UDI/DI N/A, System ID 082426020011, Serial Number 21381; UDI/DI N/A, System ID 082426120028, Serial Number 21390; UDI/DI N/A, System ID 082426030033, Serial Number 21406; UDI/DI N/A, System ID 082426060012, Serial Number 670V21422; UDI/DI N/A, System ID 082426230029, Serial Number 670W21435; UDI/DI N/A, System ID 082426230026, Serial Number 21364; UDI/DI N/A, System ID 082426100066, Serial Number 21391; UDI/DI N/A, System ID 082426130044, Serial Number 21384; UDI/DI N/A, System ID 082426310030, Serial Number 670W21427; UDI/DI N/A, System ID 082426130045, Serial Number 21403; UDI/DI N/A, System ID 082426130042, Serial Number 21375; UDI/DI N/A, System ID 082426310029, Serial Number 670V21419; UDI/DI N/A, System ID 082426080023, Serial Number 21332; UDI/DI N/A, System ID 082426230025, Serial Number 21389; UDI/DI N/A, System ID 082426050011, Serial Number 21344; UDI/DI N/A, System ID 082426140032, Serial Number 21411; UDI/DI N/A, System ID Not Available, Serial Number 21404; UDI/DI N/A, System ID NM21370, Serial Number 21370; UDI/DI N/A, System ID NM21353, Serial Number 21353; UDI/DI N/A, System ID 600055NM05, Serial Number 21341; UDI/DI N/A, System ID CS1021NM05, Serial Number 21337; UDI/DI N/A, System ID M4135184, Serial Number 21352; UDI/DI N/A, System ID M4111227, Serial Number 21379; UDI/DI N/A, System ID PF1000NM01, Serial Number 21335; UDI/DI N/A, System ID M4496956, Serial Number 21371; UDI/DI N/A, System ID Not Available, Serial Number 670V21424; UDI/DI N/A, System ID 0828260026, Serial Number 21343; UDI/DI N/A, System ID 083026100768918, Serial Number 670W21441; UDI/DI N/A, System ID Not Available, Serial Number 670W21439; UDI/DI N/A, System ID 083026868698016, Serial Number 21401; UDI/DI N/A, System ID 083026864259317, Serial Number 670V21425; UDI/DI N/A, System ID 083026280017614, Serial Number 21350; UDI/DI N/A, System ID 083026043549218, Serial Number 670W21442; UDI/DI N/A, System ID Not Available, Serial Number 670W21440; UDI/DI N/A, System ID B5190939, Serial Number 21377; UDI/DI N/A, System ID 0850260147, Serial Number 21369; UDI/DI N/A, System ID HRL0731, Serial Number 21334; UDI/DI N/A, System ID PL1580NM01, Serial Number 21347; UDI/DI N/A, System ID RU2665NM02, Serial Number 21348; UDI/DI N/A, System ID RU1044NM02, Serial Number 21410; UDI/DI N/A, System ID RU0097NM01, Serial Number 670V21414; UDI/DI N/A, System ID RU3883NM01, Serial Number 21326; UDI/DI N/A, System ID RU3829NM01, Serial Number 21340; UDI/DI N/A, System ID MEX71001, Serial Number 21372; UDI/DI N/A, System ID 0853260140, Serial Number 21349; UDI/DI N/A, System ID 0853260152, Serial Number 21412; UDI/DI N/A, System ID 0853260154, Serial Number 21413; UDI/DI N/A, System ID 0853260147, Serial Number 21380; UDI/DI N/A, System ID 0856260039, Serial Number 21382; UDI/DI N/A, System ID 06162NUC01, Serial Number 21356.
7) H3100NC: UDI/DI N/A, System ID 205933D670, Serial Number 21302; UDI/DI N/A, System ID 205975U630, Serial Number 22230; UDI/DI N/A, System ID 334287NM630, Serial Number 22099; UDI/DI N/A, System ID 251639D630, Serial Number 22010; UDI/DI N/A, System ID 205333D630, Serial Number 22052; UDI/DI N/A, System ID 479587N630, Serial Number 22158; UDI/DI N/A, System ID 479967DSC, Serial Number 22151; UDI/DI N/A, System ID 928214NMCT, Serial Number 26026/25026; UDI/DI N/A, System ID Not Available, Serial Number 26061/25060; UDI/DI N/A, System ID Not Available, Serial Number 26080/25079; UDI/DI N/A, System ID 520UMC640, Serial Number 26085/25085; UDI/DI N/A, System ID Not Available, Serial Number 22264; UDI/DI N/A, System ID 707961D630, Serial Number 22063; UDI/DI N/A, System ID 714843D630, Serial Number 22212; UDI/DI N/A, System ID 310673D630, Serial Number 22246; UDI/DI N/A, System ID 714670D630, Serial Number 22285; UDI/DI N/A, System ID 310423D670NM, Serial Number 21261; UDI/DI N/A, System ID 619474D630, Serial Number 22002; UDI/DI N/A, System ID 510428D670, Serial Number 21321; UDI/DI N/A, System ID 760778D630, Serial Number 22092; UDI/DI N/A, System ID 530244D630, Serial Number 22261; UDI/DI N/A, System ID 909599D630, Serial Number 22119; UDI/DI N/A, System ID 415353D670, Serial Number 21188; UDI/DI N/A, System ID 0004072357, Serial Number 21315; UDI/DI N/A, System ID 951303D630, Serial Number 22138; UDI/DI N/A, System ID 719587D630, Serial Number 22055; UDI/DI N/A, System ID 720848D670, Serial Number 21201; UDI/DI N/A, System ID 303788D630, Serial Number 22226; UDI/DI N/A, System ID 203384D630, Serial Number 22143; UDI/DI N/A, System ID 302430NUC630, Serial Number 22148; UDI/DI N/A, System ID 941BMCNM630, Serial Number 22160; UDI/DI N/A, System ID 813882D630, Serial Number 22244; UDI/DI N/A, System ID 00200NUC07, Serial Number 21003; UDI/DI N/A, System ID 904321DSC1, Serial Number 22040; UDI/DI N/A, System ID 850862D630, Serial Number 22139; UDI/DI N/A, System ID 352333D630, Serial Number 22263; UDI/DI N/A, System ID 904UFHNDSC2, Serial Number 21316; UDI/DI N/A, System ID 904UFHNDSC1, Serial Number 22294; UDI/DI N/A, System ID Not Available, Serial Number 22060; UDI/DI N/A, System ID OSC630, Serial Number 22112; UDI/DI N/A, System ID POIN630, Serial Number 22072; UDI/DI N/A, System ID 941LWRNM630, Serial Number 22027; UDI/DI N/A, System ID 305596D630A, Serial Number 22069; UDI/DI N/A, System ID 305596D630B, Serial Number 22085; UDI/DI N/A, System ID 305674D670, Serial Number 21062; UDI/DI N/A, System ID 904276DSC1, Serial Number 22122; UDI/DI N/A, System ID 772398630D, Serial Number 22190; UDI/DI N/A, System ID 813558D630, Serial Number 22026; UDI/DI N/A, System ID 813615D630, Serial Number 22054; UDI/DI N/A, System ID 404686NMCT, Serial Number 21044; UDI/DI N/A, System ID 770751D630, Serial Number 22127; UDI/DI N/A, System ID 770751D630C, Serial Number 22179; UDI/DI N/A, System ID 229259D630, Serial Number 22149; UDI/DI N/A, System ID 671USNHD670, Serial Number 21257; UDI/DI N/A, System ID 808485NM630, Serial Number 22081; UDI/DI N/A, System ID 808485NM640, Serial Number 26012/25014; UDI/DI N/A, System ID 808KMCNM630, Serial Number 22269; UDI/DI N/A, System ID 319364D630B, Serial Number 22097; UDI/DI N/A, System ID 319364D630A, Serial Number 22105; UDI/DI N/A, System ID 515699NM2, Serial Number 26034/25036; UDI/DI N/A, System ID 208455NM630, Serial Number 22125; UDI/DI N/A, System ID 208227NM630, Serial Number 22196; UDI/DI N/A, System ID 847842NM640, Serial Number 26089/25087; UDI/DI N/A, System ID 847842NM6402, Serial Number 26090/25102; UDI/DI N/A, System ID Not Available, Serial Number 22189; UDI/DI N/A, System ID 773282D630, Serial Number 22025; UDI/DI N/A, System ID 618842DISC1, Serial Number 22018; UDI/DI N/A, System ID 618942NM630, Serial Number 22053; UDI/DI N/A, System ID 630432D670, Serial Number 21172; UDI/DI N/A, System ID 708684D670, Serial Number 21251; UDI/DI N/A, System ID 708684D630, Serial Number 22058; UDI/DI N/A, System ID 708684O6401, Serial Number 26038/25035; UDI/DI N/A, System ID 309671SPECT, Serial Number 21023; UDI/DI N/A, System ID 309672NM2, Serial Number 26020/25017; UDI/DI N/A, System ID 309655NM640, Serial Number 26065/25059; UDI/DI N/A, System ID 618443DISC1, Serial Number 22004; UDI/DI N/A, System ID 217544PH630, Serial Number 22045; UDI/DI N/A, System ID 815564D630, Serial Number 22088; UDI/DI N/A, System ID 815564O640, Serial Number 26004/25004; UDI/DI N/A, System ID 217383D630, Serial Number 22159; UDI/DI N/A, System ID 847872O640, Serial Number 26013/25013; UDI/DI N/A, System ID 260665D630, Serial Number 22297; UDI/DI N/A, System ID 260920D630, Serial Number 22200; UDI/DI N/A, System ID 812280D630, Serial Number 22235; UDI/DI N/A, System ID 317887D630, Serial Number 22041; UDI/DI N/A, System ID 765447D630, Serial Number 22141; UDI/DI N/A, System ID 812949D630, Serial Number 22247; UDI/DI N/A, System ID 574372D630, Serial Number 22192; UDI/DI N/A, System ID HAYSD6301, Serial Number 22259; UDI/DI N/A, System ID HAYSD6302, Serial Number 22278; UDI/DI N/A, System ID 913345D630, Serial Number 22034; UDI/DI N/A, System ID 859239D630, Serial Number 22157; UDI/DI N/A, System ID 270956NM640, Serial Number 26018/25016; UDI/DI N/A, System ID 270417D630, Serial Number 22123; UDI/DI N/A, System ID 318448D630, Serial Number 22042; UDI/DI N/A, System ID 318798D630, Serial Number 22036; UDI/DI N/A, System ID 617638DSV670, Serial Number 21032; UDI/DI N/A, System ID 617638D630, Serial Number 22164; UDI/DI N/A, System ID 978354DSV630, Serial Number 22067; UDI/DI N/A, System ID 413598D630, Serial Number 22282; UDI/DI N/A, System ID 413794OPTIMA, Serial Number 26050/25050; UDI/DI N/A, System ID 410955D670, Serial Number 21221; UDI/DI N/A, System ID 410D6701, Serial Number 21127; UDI/DI N/A, System ID 301877D630, Serial Number 22046; UDI/DI N/A, System ID 301557D670, Serial Number 21317; UDI/DI N/A, System ID 410543NUC640, Serial Number 26025/25024; UDI/DI N/A, System ID 207664NM630, Serial Number 22098; UDI/DI N/A, System ID 269966D630, Serial Number 22240; UDI/DI N/A, System ID 616267D670, Serial Number 21291; UDI/DI N/A, System ID 269945D630, Serial Number 22094; UDI/DI N/A, System ID 616392D630, Serial Number 22220; UDI/DI N/A, System ID 616392D640, Serial Number 26054/25052; UDI/DI N/A, System ID 989227D630, Serial Number 22082; UDI/DI N/A, System ID 320762DSC, Serial Number 22253; UDI/DI N/A, System ID 763795DSC670, Serial Number 21279; UDI/DI N/A, System ID 218736NM640, Serial Number 26057/25054; UDI/DI N/A, System ID 651DSC630, Serial Number 22050; UDI/DI N/A, System ID 952442DSC640, Serial Number 26067/25064; UDI/DI N/A, System ID WH231NM630, Serial Number 22144; UDI/DI N/A, System ID 660890D670, Serial Number 21224; UDI/DI N/A, System ID 417347D630, Serial Number 22286; UDI/DI N/A, System ID 417781D630, Serial Number 22032; UDI/DI N/A, System ID 816234D630, Serial Number 22077; UDI/DI N/A, System ID 816234D640, Serial Number 26011/25018; UDI/DI N/A, System ID 417533D630, Serial Number 22057; UDI/DI N/A, System ID 816415D630, Serial Number 22210; UDI/DI N/A, System ID 314BARNNM2, Serial Number 22270; UDI/DI N/A, System ID 417256D630, Serial Number 22227; UDI/DI N/A, System ID 601264D630, Serial Number 22250; UDI/DI N/A, System ID 601354D630, Serial Number 22024; UDI/DI N/A, System ID 601798D630, Serial Number 22047; UDI/DI N/A, System ID 406237NMDISC, Serial Number 26037/25037; UDI/DI N/A, System ID 406657BC640, Serial Number 26049/25051; UDI/DI N/A, System ID 828213MHD630, Serial Number 22219; UDI/DI N/A, System ID 828213MHO640, Serial Number 26075/25074; UDI/DI N/A, System ID 704355D630, Serial Number 22012; UDI/DI N/A, System ID DUKECCDSV670NM, Serial Number 21111; UDI/DI N/A, System ID DUKEDMP670NM, Serial Number 21189; UDI/DI N/A, System ID DR670NM, Serial Number 21274; UDI/DI N/A, System ID DMP630A, Serial Number 22131; UDI/DI N/A, System ID DMP630B, Serial Number 22135; UDI/DI N/A, System ID DR630NM, Serial Number 22273; UDI/DI N/A, System ID PITT670, Serial Number 21065; UDI/DI N/A, System ID VMC670, Serial Number 21305; UDI/DI N/A, System ID 910FHHOKENM630, Serial Number 22150; UDI/DI N/A, System ID 919954NMDISC, Serial Number 26036/25042; UDI/DI N/A, System ID JHDSV630NM, Serial Number 22043; UDI/DI N/A, System ID 308455D630, Serial Number 22211; UDI/DI N/A, System ID D630GEMINI01, Serial Number 22061; UDI/DI N/A, System ID D630GEMINI02, Serial Number 22062; UDI/DI N/A, System ID 603354NM630, Serial Number 22145; UDI/DI N/A, System ID 201858GDSL, Serial Number 22014; UDI/DI N/A, System ID 732321D630, Serial Number 22236; UDI/DI N/A, System ID 201418D630, Serial Number 22096; UDI/DI N/A, System ID 609978D630, Serial Number 22101; UDI/DI N/A, System ID 856355D630, Serial Number 22134; UDI/DI N/A, System ID 856247NM, Serial Number 21030; UDI/DI N/A, System ID 856247D670, Serial Number 21157; UDI/DI N/A, System ID 609835D630, Serial Number 22202; UDI/DI N/A, System ID Not Available, Serial Number 22231; UDI/DI N/A, System ID Not Available, Serial Number 22304; UDI/DI N/A, System ID 702407NM630, Serial Number 22154; UDI/DI N/A, System ID 702388VNM2, Serial Number 22091; UDI/DI N/A, System ID Not Available, Serial Number 22152; UDI/DI N/A, System ID 775STMANM630A, Serial Number 22137; UDI/DI N/A, System ID 775STMANM630B, Serial Number 22187; UDI/DI N/A, System ID 607763DIS630, Serial Number 22156; UDI/DI N/A, System ID Not Available, Serial Number 22181; UDI/DI N/A, System ID 516635D630, Serial Number 22255; UDI/DI N/A, System ID 716372NM630, Serial Number 22048; UDI/DI N/A, System ID 845454D630, Serial Number 22017; UDI/DI N/A, System ID 585922NM630, Serial Number 22068; UDI/DI N/A, System ID 914366D630, Serial Number 22217; UDI/DI N/A, System ID 330596D630, Serial Number 22289; UDI/DI N/A, System ID 216778D630, Serial Number 22224; UDI/DI N/A, System ID 216778D640, Serial Number 26071/25069; UDI/DI N/A, System ID 614NCH670, Serial Number 21114; UDI/DI N/A, System ID 614NCH630, Serial Number 22039; UDI/DI N/A, System ID 937SNHC630, Serial Number 22059; UDI/DI N/A, System ID 330386D630, Serial Number 22117; UDI/DI N/A, System ID 740687D630, Serial Number 22288; UDI/DI N/A, System ID SOMCD630, Serial Number 22252; UDI/DI N/A, System ID SOMCOPT640, Serial Number 26077/25073; UDI/DI N/A, System ID 419SAN1, Serial Number 22205; UDI/DI N/A, System ID 330965D630, Serial Number 22238; UDI/DI N/A, System ID 580531NM630, Serial Number 22049; UDI/DI N/A, System ID 405271CX31, Serial Number 26069/25063; UDI/DI N/A, System ID 918502DIS1, Serial Number 22064; UDI/DI N/A, System ID 541276NM640, Serial Number 26031/25032; UDI/DI N/A, System ID 610402D670NM1, Serial Number 21193; UDI/DI N/A, System ID 908859NM630, Serial Number 22193; UDI/DI N/A, System ID 814274D630, Serial Number 22272; UDI/DI N/A, System ID 814623D630, Serial Number 22007; UDI/DI N/A, System ID 717782640NM, Serial Number 26010/25010; UDI/DI N/A, System ID 717272D670, Serial Number 21303; UDI/DI N/A, System ID 717791NMCT670, Serial Number 21276; UDI/DI N/A, System ID 215728OPT640, Serial Number 26021/25019; UDI/DI N/A, System ID 412647D670R3, Serial Number 21309; UDI/DI N/A, System ID 610869D630, Serial Number 22203; UDI/DI N/A, System ID 864512DISC640, Serial Number 26076/25075; UDI/DI N/A, System ID 843797TD630, Serial Number 22103; UDI/DI N/A, System ID 803751D670, Serial Number 21105; UDI/DI N/A, System ID 843347D630, Serial Number 22095; UDI/DI N/A, System ID 803751D630, Serial Number 22214; UDI/DI N/A, System ID Not Available, Serial Number 22167; UDI/DI N/A, System ID 864530DISC70, Serial Number 21298; UDI/DI N/A, System ID 605622D670, Serial Number 21263; UDI/DI N/A, System ID 605996D630, Serial Number 22174; UDI/DI N/A, System ID 605322D630, Serial Number 22136; UDI/DI N/A, System ID 605336NM1, Serial Number 26039/25041; UDI/DI N/A, System ID 901861D630, Serial Number 22251; UDI/DI N/A, System ID 901516GO640, Serial Number 26014/25012; UDI/DI N/A, System ID 615316D630, Serial Number 22275; UDI/DI N/A, System ID 423495D670, Serial Number 21074; UDI/DI N/A, System ID 731541D630, Serial Number 22245; UDI/DI N/A, System ID 931461NM, Serial Number 22168; UDI/DI N/A, System ID 901226D630, Serial Number 22124; UDI/DI N/A, System ID 615893NM2, Serial Number 21006; UDI/DI N/A, System ID 615893MMCNM1, Serial Number 21182; UDI/DI N/A, System ID 615322NM5, Serial Number 21078; UDI/DI N/A, System ID 615342D630, Serial Number 22296; UDI/DI N/A, System ID 931393NM2, Serial Number 22070; UDI/DI N/A, System ID 972747NM670, Serial Number 21202; UDI/DI N/A, System ID Not Available, Serial Number 22277; UDI/DI N/A, System ID 409212NM630, Serial Number 22126; UDI/DI N/A, System ID 361761DNM1, Serial Number 22258; UDI/DI N/A, System ID 682885NM640, Serial Number 21088; UDI/DI N/A, System ID 817263NM630, Serial Number 22276; UDI/DI N/A, System ID 817250NM640, Serial Number 26007/25006; UDI/DI N/A, System ID 281737NM630, Serial Number 22213; UDI/DI N/A, System ID 713566NM640, Serial Number 26029/25031; UDI/DI N/A, System ID 281540D630, Serial Number 22030; UDI/DI N/A, System ID 956523D630, Serial Number 22013; UDI/DI N/A, System ID 903GSD630, Serial Number 22056; UDI/DI N/A, System ID 806775NMCT1, Serial Number 26093/25108; UDI/DI N/A, System ID 936NMD630, Serial Number 22132; UDI/DI N/A, System ID 830RESOLUTE630D, Serial Number 22257; UDI/DI N/A, System ID 469814NM630, Serial Number 22066; UDI/DI N/A, System ID 972981NM630, Serial Number 22281; UDI/DI N/A, System ID 210617670D1, Serial Number 21072; UDI/DI N/A, System ID 972935D670, Serial Number 21045; UDI/DI N/A, System ID 972935NM630, Serial Number 22300; UDI/DI N/A, System ID 281BAYNM630, Serial Number 22265; UDI/DI N/A, System ID 801714D630, Serial Number 22087; UDI/DI N/A, System ID 703558O640, Serial Number 26078/25078; UDI/DI N/A, System ID 540332D670, Serial Number 21149; UDI/DI N/A, System ID 757736D630, Serial Number 22195; UDI/DI N/A, System ID 540689D640, Serial Number 26044/25043; UDI/DI N/A, System ID 804764D630B, Serial Number 22155; UDI/DI N/A, System ID 804764D630A, Serial Number 22170; UDI/DI N/A, System ID 804675D630A, Serial Number 22065; UDI/DI N/A, System ID 804330D630, Serial Number 22292; UDI/DI N/A, System ID 804330NM640, Serial Number 26074/25072; UDI/DI N/A, System ID 509546NM630, Serial Number 22182; UDI/DI N/A, System ID 608356D630, Serial Number 22153; UDI/DI N/A, System ID 715735OPT1, Serial Number 26028/25022; UDI/DI N/A, System ID 262251D670, Serial Number 21297; UDI/DI N/A, System ID 262798D630, Serial Number 22163; UDI/DI N/A, System ID 414805OPT640, Serial Number 26088/25088; UDI/DI N/A, System ID Shipped, Serial Number 21102; UDI/DI N/A, System ID Not Available, Serial Number 22218; UDI/DI N/A, System ID 262577OPT1, Serial Number 26068/25066; UDI/DI N/A, System ID 608643D630, Serial Number 22243; UDI/DI N/A, System ID 262836OPT640, Serial Number 26079/25077; UDI/DI N/A, System ID PRINCE630, Serial Number 22029; UDI/DI N/A, System ID 304797D630, Serial Number 22165; UDI/DI N/A, System ID 307362D670, Serial Number 21223; UDI/DI N/A, System ID NM22237, Serial Number 22237; UDI/DI N/A, System ID NM22090, Serial Number 22090; UDI/DI N/A, System ID NM22283, Serial Number 22283; UDI/DI N/A, System ID 0910263243, Serial Number 21049; UDI/DI N/A, System ID 0910262319, Serial Number 21066; UDI/DI N/A, System ID 83108952125, Serial Number 26091/25086; UDI/DI N/A, System ID 83109682777, Serial Number 26083/25083; UDI/DI N/A, System ID 0910262344, Serial Number 21145; UDI/DI N/A, System ID 0910262304, Serial Number 21020; UDI/DI N/A, System ID 0910262310, Serial Number 21041; UDI/DI N/A, System ID 0910262297, Serial Number 21017; UDI/DI N/A, System ID 0910262322, Serial Number 21075; UDI/DI N/A, System ID 0910262325, Serial Number 21082; UDI/DI N/A, System ID 0910263223, Serial Number 21013; UDI/DI N/A, System ID 0910263256, Serial Number 26002/25007; UDI/DI N/A, System ID 0910264141, Serial Number 21081; UDI/DI N/A, System ID 0910264135, Serial Number 21119; UDI/DI N/A, System ID 0910264147, Serial Number 21147; UDI/DI N/A, System ID 0910265075, Serial Number 21140; UDI/DI N/A, System ID 0910265074, Serial Number 21144; UDI/DI N/A, System ID 0910267022, Serial Number 21079; UDI/DI N/A, System ID 0910263231, Serial Number 21039; UDI/DI N/A, System ID 0910263235, Serial Number 21002; UDI/DI N/A, System ID 0910263253, Serial Number 26005/25005; UDI/DI N/A, System ID 83104206943, Serial Number 26066/25065; UDI/DI N/A, System ID 0910263250, Serial Number 21150; UDI/DI N/A, System ID 83104205567, Serial Number 26087/25091; UDI/DI N/A, System ID 0910263228, Serial Number 21029; UDI/DI N/A, System ID 0910263239, Serial Number 21080; UDI/DI N/A, System ID 83094241426, Serial Number 26032/25034; UDI/DI N/A, System ID BY4033NM01, Serial Number 21220; UDI/DI N/A, System ID 030151NU15, Serial Number 22080; UDI/DI N/A, System ID 030232NU15, Serial Number 22020; UDI/DI N/A, System ID 030082NU13, Serial Number 21104; UDI/DI N/A, System ID 010120NU19, Serial Number 21001; UDI/DI N/A, System ID 030037NU08, Serial Number 21214; UDI/DI N/A, System ID 220826NU03, Serial Number 21283; UDI/DI N/A, System ID 210002NU11, Serial Number 21226; UDI/DI N/A, System ID 210002NU11, Serial Number 21229; UDI/DI N/A, System ID 190900NU01, Serial Number 21254; UDI/DI N/A, System ID 100032NU05, Serial Number 21132; UDI/DI N/A, System ID 110059NU01, Serial Number 21249; UDI/DI N/A, System ID 190163NU04, Serial Number 21162; UDI/DI N/A, System ID 190163NU06, Serial Number 21167; UDI/DI N/A, System ID 080041NU04, Serial Number 21178; UDI/DI N/A, System ID 110017NU06, Serial Number 21056; UDI/DI N/A, System ID 030029NU05, Serial Number 22038; UDI/DI N/A, System ID 100039NU02, Serial Number 21215; UDI/DI N/A, System ID 110012NU05, Serial Number 21275; UDI/DI N/A, System ID 826395NU01, Serial Number 22184; UDI/DI N/A, System ID 210060NU02, Serial Number 21050; UDI/DI N/A, System ID NM22280, Serial Number 22280; UDI/DI N/A, System ID NM22191, Serial Number 22191; UDI/DI N/A, System ID NM22162, Serial Number 22162; UDI/DI N/A, System ID NM22279, Serial Number 22279; UDI/DI N/A, System ID NM22232, Serial Number 22232; UDI/DI N/A, System ID NM22130, Serial Number 22130; UDI/DI N/A, System ID NM22233, Serial Number 22233; UDI/DI N/A, System ID NM22118, Serial Number 22118; UDI/DI N/A, System ID NM21273, Serial Number 21273; UDI/DI N/A, System ID NM22249, Serial Number 22249; UDI/DI N/A, System ID NM22225, Serial Number 22225; UDI/DI N/A, System ID NM22267, Serial Number 22267; UDI/DI N/A, System ID NM21259, Serial Number 21259; UDI/DI N/A, System ID NM21269, Serial Number 21269; UDI/DI N/A, System ID NM22291, Serial Number 22291; UDI/DI N/A, System ID NM26081, Serial Number 26081/25082; UDI/DI N/A, System ID NM22206, Serial Number 22206; UDI/DI N/A, System ID NM22073, Serial Number 22073; UDI/DI N/A, System ID NM22074, Serial Number 22074; UDI/DI N/A, System ID NM22120, Serial Number 22120; UDI/DI N/A, System ID BG4009NM01, Serial Number 21164; UDI/DI N/A, System ID 403943D670, Serial Number 21184; UDI/DI N/A, System ID 403943D670B, Serial Number 21194; UDI/DI N/A, System ID 403670D670, Serial Number 21282; UDI/DI N/A, System ID 780735D670A, Serial Number 21058; UDI/DI N/A, System ID 403343D670, Serial Number 21200; UDI/DI N/A, System ID 250370D670, Serial Number 21143; UDI/DI N/A, System ID 204726D670NM, Serial Number 21042; UDI/DI N/A, System ID 204237D670, Serial Number 21308; UDI/DI N/A, System ID 514842AD670, Serial Number 21077; UDI/DI N/A, System ID 613548D670, Serial Number 21115; UDI/DI N/A, System ID 519646D630, Serial Number 22186; UDI/DI N/A, System ID 905472D670, Serial Number 21156; UDI/DI N/A, System ID 613721O670, Serial Number 26051/25057; UDI/DI N/A, System ID 905883D670, Serial Number 21085; UDI/DI N/A, System ID 905684D670B, Serial Number 21135; UDI/DI N/A, System ID 905684D670A, Serial Number 21139; UDI/DI N/A, System ID 416663D630, Serial Number 22208; UDI/DI N/A, System ID 905684D630, Serial Number 22051; UDI/DI N/A, System ID 519973D670, Serial Number 21094; UDI/DI N/A, System ID 418549D670A, Serial Number 21122; UDI/DI N/A, System ID 418549D670B, Serial Number 21123; UDI/DI N/A, System ID 514338D670, Serial Number 21137; UDI/DI N/A, System ID 514876D670, Serial Number 21210; UDI/DI N/A, System ID 514934D670PC, Serial Number 21278; UDI/DI N/A, System ID 514934D670AC, Serial Number 21294; UDI/DI N/A, System ID 514934D670PB, Serial Number 21295; UDI/DI N/A, System ID 514934D670PB, Serial Number 21296; UDI/DI N/A, System ID 514934D670AE, Serial Number 21299; UDI/DI N/A, System ID 514848D670, Serial Number 21048; UDI/DI N/A, System ID 514842AD670CT, Serial Number 21300; UDI/DI N/A, System ID 514281D670, Serial Number 21061; UDI/DI N/A, System ID 514843AD670, Serial Number 21253; UDI/DI N/A, System ID 514890D670G, Serial Number 22114; UDI/DI N/A, System ID 819563D670B, Serial Number 21198; UDI/DI N/A, System ID 082426040044, Serial Number 21113; UDI/DI N/A, System ID 082426040061, Serial Number 21290; UDI/DI N/A, System ID 082426040062, Serial Number 21286; UDI/DI N/A, System ID 082426040043, Serial Number 21083; UDI/DI N/A, System ID 082426040052, Serial Number 21213; UDI/DI N/A, System ID 082426040059, Serial Number 21240; UDI/DI N/A, System ID 082426040051, Serial Number 21168; UDI/DI N/A, System ID 082426130029, Serial Number 21028; UDI/DI N/A, System ID 082426040053, Serial Number 21222; UDI/DI N/A, System ID 082426060007, Serial Number 21243; UDI/DI N/A, System ID 082426150026, Serial Number 21131; UDI/DI N/A, System ID 082426200011, Serial Number 22284; UDI/DI N/A, System ID 082426130030, Serial Number 21101; UDI/DI N/A, System ID 082426030029, Serial Number 22293; UDI/DI N/A, System ID 082426160042, Serial Number 21183; UDI/DI N/A, System ID 082426050009, Serial Number 21287; UDI/DI N/A, System ID 082426120024, Serial Number 21242; UDI/DI N/A, System ID 082426090029, Serial Number 21118; UDI/DI N/A, System ID 082426160043, Serial Number 21265; UDI/DI N/A, System ID 082426070035, Serial Number 21312; UDI/DI N/A, System ID 082426070028, Serial Number 21052; UDI/DI N/A, System ID 082426070034, Serial Number 21231; UDI/DI N/A, System ID 082426070030, Serial Number 21092; UDI/DI N/A, System ID 082426070031, Serial Number 21166; UDI/DI N/A, System ID 082426010018, Serial Number 21288; UDI/DI N/A, System ID 082426090030, Serial Number 21138; UDI/DI N/A, System ID 082426090036, Serial Number 21310; UDI/DI N/A, System ID 082426210020, Serial Number 21165; UDI/DI N/A, System ID 082426210024, Serial Number 22290; UDI/DI N/A, System ID 082426120029, Serial Number 22076; UDI/DI N/A, System ID 082426020008, Serial Number 21270; UDI/DI N/A, System ID 082426030028, Serial Number 22169; UDI/DI N/A, System ID 082426060009, Serial Number 21292; UDI/DI N/A, System ID 082426060005, Serial Number 21158; UDI/DI N/A, System ID 082426060008, Serial Number 21271; UDI/DI N/A, System ID 082426080022, Serial Number 21230; UDI/DI N/A, System ID 082426310026, Serial Number 21241; UDI/DI N/A, System ID 082426100060, Serial Number 21314; UDI/DI N/A, System ID 082426100052, Serial Number 21212; UDI/DI N/A, System ID 082426080020, Serial Number 21076; UDI/DI N/A, System ID 082426230020, Serial Number 21207; UDI/DI N/A, System ID 082426230019, Serial Number 21239; UDI/DI N/A, System ID 82426270009, Serial Number 22287; UDI/DI N/A, System ID NM22129, Serial Number 22129; UDI/DI N/A, System ID NM22102, Serial Number 22102; UDI/DI N/A, System ID NM22116, Serial Number 22116; UDI/DI N/A, System ID NM22161, Serial Number 22161; UDI/DI N/A, System ID NM22303, Serial Number 22303; UDI/DI N/A, System ID NM22198, Serial Number 22198; UDI/DI N/A, System ID NM22201, Serial Number 22201; UDI/DI N/A, System ID H3001NUC01, Serial Number 22107; UDI/DI N/A, System ID CS6104NM01, Serial Number 22301; UDI/DI N/A, System ID DK1567NM01, Serial Number 21005; UDI/DI N/A, System ID DK1054NM03, Serial Number 26009/25008; UDI/DI N/A, System ID DK1029NU14, Serial Number 21019; UDI/DI N/A, System ID EG1238NM01, Serial Number 22216; UDI/DI N/A, System ID EE4020NM03, Serial Number 21154; UDI/DI N/A, System ID ET1012NM01, Serial Number 22274; UDI/DI N/A, System ID FI1052MN01, Serial Number 21009; UDI/DI N/A, System ID X6010810, Serial Number 21236; UDI/DI N/A, System ID M9886847, Serial Number 21067; UDI/DI N/A, System ID M4144126, Serial Number 21187; UDI/DI N/A, System ID M9409545, Serial Number 21035; UDI/DI N/A, System ID M251400603, Serial Number 21128; UDI/DI N/A, System ID A4169312, Serial Number 21141; UDI/DI N/A, System ID V4169306, Serial Number 21197; UDI/DI N/A, System ID B1768013, Serial Number 21235; UDI/DI N/A, System ID M4476424, Serial Number 21095; UDI/DI N/A, System ID M4476428, Serial Number 21318; UDI/DI N/A, System ID M4476428, Serial Number 22016; UDI/DI N/A, System ID M5172553, Serial Number 21064; UDI/DI N/A, System ID GP1000NM01, Serial Number 21093; UDI/DI N/A, System ID M4191123, Serial Number 21250; UDI/DI N/A, System ID V2312613, Serial Number 22271; UDI/DI N/A, System ID X4144501, Serial Number 21073; UDI/DI N/A, System ID M2002713, Serial Number 21070; UDI/DI N/A, System ID M2269850, Serial Number 21311; UDI/DI N/A, System ID M2269852, Serial Number 21313; UDI/DI N/A, System ID M4319305, Serial Number 26063/25053; UDI/DI N/A, System ID M5480777, Serial Number 21121; UDI/DI N/A, System ID M4194042, Serial Number 21186; UDI/DI N/A, System ID M4134637, Serial Number 21033; UDI/DI N/A, System ID A4194445, Serial Number 21304; UDI/DI N/A, System ID A4194844, Serial Number 21134; UDI/DI N/A, System ID M4198090, Serial Number 21037; UDI/DI N/A, System ID M4144868, Serial Number 21306; UDI/DI N/A, System ID M4200117, Serial Number 21284; UDI/DI N/A, System ID X204493801, Serial Number 21248; UDI/DI N/A, System ID M204493816, Serial Number 26092/25094; UDI/DI N/A, System ID V4144610, Serial Number 21152; UDI/DI N/A, System ID V6414107, Serial Number 22079; UDI/DI N/A, System ID M4210246, Serial Number 21021; UDI/DI N/A, System ID M348992917, Serial Number 21146; UDI/DI N/A, System ID P42114106, Serial Number 21258; UDI/DI N/A, System ID M4215577, Serial Number 21159; UDI/DI N/A, System ID M4505290, Serial Number 21063; UDI/DI N/A, System ID 126387NU01, Serial Number 21112; UDI/DI N/A, System ID 407431NU01, Serial Number 22078; UDI/DI N/A, System ID 870939NU02, Serial Number 22108; UDI/DI N/A, System ID 870939NU01, Serial Number 22109; UDI/DI N/A, System ID 221780NU01, Serial Number 21196; UDI/DI N/A, System ID PC3003NU01, Serial Number 22023; UDI/DI N/A, System ID PC4047NU01, Serial Number 22001; UDI/DI N/A, System ID Not Available, Serial Number 26041/25039; UDI/DI N/A, System ID 600791NU01, Serial Number 22115; UDI/DI N/A, System ID HC1992NU05, Serial Number 21262; UDI/DI N/A, System ID PC3720NU03, Serial Number 22256; UDI/DI N/A, System ID Not Available, Serial Number 26015/25011; UDI/DI N/A, System ID HG4437NU04, Serial Number 22140; UDI/DI N/A, System ID ULUE01NU02, Serial Number 26003/25027; UDI/DI N/A, System ID UX2305NU01, Serial Number 21024; UDI/DI N/A, System ID PMAB01NU04, Serial Number 22011; UDI/DI N/A, System ID HC0038NU01, Serial Number 22147; UDI/DI N/A, System ID HT2106NU08, Serial Number 21217; UDI/DI N/A, System ID HC0863NU02, Serial Number 22089; UDI/DI N/A, System ID PC2306NU02, Serial Number 22121; UDI/DI N/A, System ID HC1992NU06, Serial Number 22194; UDI/DI N/A, System ID H2078NUC07, Serial Number 22178; UDI/DI N/A, System ID H2078NUC07, Serial Number 26035/25044; UDI/DI N/A, System ID H2014NUC11, Serial Number 22229; UDI/DI N/A, System ID 0828260021, Serial Number 21170; UDI/DI N/A, System ID 0828260022, Serial Number 21199; UDI/DI N/A, System ID 0828260023, Serial Number 21255; UDI/DI N/A, System ID 083026001113611, Serial Number 22005; UDI/DI N/A, System ID 083026863966014, Serial Number 26052/25048; UDI/DI N/A, System ID 083026200011213, Serial Number 22133; UDI/DI N/A, System ID 083026201006810, Serial Number 21004; UDI/DI N/A, System ID 083026800008113, Serial Number 26024/25025; UDI/DI N/A, System ID 083026023683713, Serial Number 21053; UDI/DI N/A, System ID Not Available, Serial Number 26045; UDI/DI N/A, System ID IE1018MN03, Serial Number 21155; UDI/DI N/A, System ID IL1062NM29, Serial Number 21129; UDI/DI N/A, System ID IL1041NM30, Serial Number 21031; UDI/DI N/A, System ID A51051127, Serial Number 21163; UDI/DI N/A, System ID A5131865, Serial Number 22035; UDI/DI N/A, System ID Not Available, Serial Number 26056/25058; UDI/DI N/A, System ID A195945613, Serial Number 21244; UDI/DI N/A, System ID A5129983, Serial Number 21012; UDI/DI N/A, System ID B5140618, Serial Number 21151; UDI/DI N/A, System ID A5384208, Serial Number 22022; UDI/DI N/A, System ID A51142126, Serial Number 21059; UDI/DI N/A, System ID A5125139, Serial Number 21185; UDI/DI N/A, System ID A5141727, Serial Number 26084/25081; UDI/DI N/A, System ID A5196344, Serial Number 21205; UDI/DI N/A, System ID A5366307, Serial Number 22086; UDI/DI N/A, System ID A5366308, Serial Number 26008/25009; UDI/DI N/A, System ID NT3059, Serial Number 22204; UDI/DI N/A, System ID NTE002, Serial Number 26016/25030; UDI/DI N/A, System ID NTE007, Serial Number 26042/25038; UDI/DI N/A, System ID NTE005, Serial Number 26060/25061; UDI/DI N/A, System ID NT3100, Serial Number 22188; UDI/DI N/A, System ID NT3006, Serial Number 22215; UDI/DI N/A, System ID NTE004, Serial Number 26064/25062; UDI/DI N/A, System ID NT3015, Serial Number 22242; UDI/DI N/A, System ID NT3002, Serial Number 22104; UDI/DI N/A, System ID NT3014, Serial Number 22234; UDI/DI N/A, System ID NT3012, Serial Number 22221; UDI/DI N/A, System ID NT3005, Serial Number 22171; UDI/DI N/A, System ID NT3020, Serial Number 22111; UDI/DI N/A, System ID NT3011, Serial Number 22183; UDI/DI N/A, System ID NTE006, Serial Number 26059/25056; UDI/DI N/A, System ID NT3010, Serial Number 22071; UDI/DI N/A, System ID Not Available, Serial Number 26040/25029; UDI/DI N/A, System ID NT3007, Serial Number 22209; UDI/DI N/A, System ID NT1001, Serial Number 21089; UDI/DI N/A, System ID NT2001, Serial Number 21100; UDI/DI N/A, System ID NT1002, Serial Number 21097; UDI/DI N/A, System ID NTE010, Serial Number 26073/25070; UDI/DI N/A, System ID NT1006, Serial Number 21136; UDI/DI N/A, System ID NT2003, Serial Number 21245; UDI/DI N/A, System ID NT3004, Serial Number 22172; UDI/DI N/A, System ID NT1008, Serial Number T2AG12004/22044; UDI/DI N/A, System ID NT1007, Serial Number T2AG12005/93BH5; UDI/DI N/A, System ID NT3030, Serial Number 22228; UDI/DI N/A, System ID NTE001, Serial Number 24060; UDI/DI N/A, System ID NT3013, Serial Number 22239; UDI/DI N/A, System ID NT1019, Serial Number 21319; UDI/DI N/A, System ID NT1008, Serial Number 22044; UDI/DI N/A, System ID NT3003, Serial Number 22110; UDI/DI N/A, System ID NT3008, Serial Number 22199; UDI/DI N/A, System ID NT3009, Serial Number 22222; UDI/DI N/A, System ID NT3033, Serial Number 22223; UDI/DI N/A, System ID NT3021, Serial Number 22299; UDI/DI N/A, System ID 0850260118, Serial Number 21016; UDI/DI N/A, System ID 0850260138, Serial Number 21266; UDI/DI N/A, System ID 0850260137, Serial Number 22176; UDI/DI N/A, System ID 0850260134, Serial Number 22037; UDI/DI N/A, System ID 0850260128, Serial Number 21103; UDI/DI N/A, System ID 0850260142, Serial Number 22295; UDI/DI N/A, System ID 0850260141, Serial Number 21307; UDI/DI N/A, System ID 0850260136, Serial Number 22173; UDI/DI N/A, System ID 0850260132, Serial Number 21125; UDI/DI N/A, System ID 0850260125, Serial Number 22093; UDI/DI N/A, System ID 0850260122, Serial Number 21040; UDI/DI N/A, System ID 0850260131, Serial Number 21060; UDI/DI N/A, System ID 0850260140, Serial Number 21289; UDI/DI N/A, System ID NM21247, Serial Number 21247; UDI/DI N/A, System ID 0856267000, Serial Number 21285; UDI/DI N/A, System ID NA1009NM01, Serial Number 21237; UDI/DI N/A, System ID AMS1330, Serial Number 21204; UDI/DI N/A, System ID HOR0281, Serial Number 21209; UDI/DI N/A, System ID RTD0739, Serial Number 22008; UDI/DI N/A, System ID ZWL0630, Serial Number 21148; UDI/DI N/A, System ID NO1015MN15, Serial Number 26033/25033; UDI/DI N/A, System ID NO1018MN06, Serial Number 21126; UDI/DI N/A, System ID NO1087MN09, Serial Number 21068; UDI/DI N/A, System ID NO1012MN07, Serial Number 21280; UDI/DI N/A, System ID NO1035MN06, Serial Number 22009; UDI/DI N/A, System ID NO1088MN16, Serial Number 21211; UDI/DI N/A, System ID 600092NM11, Serial Number 21026; UDI/DI N/A, System ID NM26030, Serial Number 26030/25028; UDI/DI N/A, System ID NM22207, Serial Number 22207; UDI/DI N/A, System ID RU1493NM01, Serial Number 21106; UDI/DI N/A, System ID RU3637NM01, Serial Number 21018; UDI/DI N/A, System ID RU7187NM01, Serial Number 21109; UDI/DI N/A, System ID RU6340NM01, Serial Number 21110; UDI/DI N/A, System ID RU3880NM01, Serial Number 21161; UDI/DI N/A, System ID RU2581NM01, Serial Number 21173; UDI/DI N/A, System ID RU7174NM01, Serial Number 21190; UDI/DI N/A, System ID RU3713NM01, Serial Number 21071; UDI/DI N/A, System ID RU3623NM01, Serial Number 21025; UDI/DI N/A, System ID RU7175NM01, Serial Number 21130; UDI/DI N/A, System ID RU1095NM03, Serial Number 21142; UDI/DI N/A, System ID RU1279NM02, Serial Number 21180; UDI/DI N/A, System ID RU1516NM02, Serial Number 21246; UDI/DI N/A, System ID RU1199NM01, Serial Number 21267; UDI/DI N/A, System ID RU1107NM01, Serial Number 21322; UDI/DI N/A, System ID RU1516NM01, Serial Number 22185; UDI/DI N/A, System ID RU7505NM01, Serial Number 21098; UDI/DI N/A, System ID RU3828NM01, Serial Number 21195; UDI/DI N/A, System ID RU2050NM02, Serial Number 22260; UDI/DI N/A, System ID RU3463NM01, Serial Number 21087; UDI/DI N/A, System ID RU1136NM01, Serial Number 22083; UDI/DI N/A, System ID RU3900NM01, Serial Number 21090; UDI/DI N/A, System ID RU3451NM01, Serial Number 21011; UDI/DI N/A, System ID RU3467NM01, Serial Number 21160; UDI/DI N/A, System ID RU3453NM01, Serial Number 21233; UDI/DI N/A, System ID 0847260029, Serial Number 21219; UDI/DI N/A, System ID 6073MI0002, Serial Number 26082/25084; UDI/DI N/A, System ID ZA2231NM01, Serial Number 21260; UDI/DI N/A, System ID ZA2766NM01, Serial Number 22268; UDI/DI N/A, System ID FE416061, Serial Number 21047; UDI/DI N/A, System ID CEZ01529, Serial Number 21252; UDI/DI N/A, System ID MEX68915, Serial Number 21007; UDI/DI N/A, System ID 083026801595214, Serial Number 22248; UDI/DI N/A, System ID D007NU12, Serial Number 21175; UDI/DI N/A, System ID D007NU16, Serial Number 26055/25049; UDI/DI N/A, System ID O009NU09, Serial Number 22113; UDI/DI N/A, System ID M001NU42, Serial Number 21203; UDI/DI N/A, System ID M001NU43, Serial Number 21218; UDI/DI N/A, System ID H002NU03, Serial Number 22075; UDI/DI N/A, System ID 259130NU02, Serial Number 26058/25055; UDI/DI N/A, System ID 475260NU01, Serial Number 21177; UDI/DI N/A, System ID 260010NU06, Serial Number 21191; UDI/DI N/A, System ID 0853260094, Serial Number 21099; UDI/DI N/A, System ID 0853260132, Serial Number 22266; UDI/DI N/A, System ID 0853260099, Serial Number 21171; UDI/DI N/A, System ID 0856260035, Serial Number 21169; UDI/DI N/A, System ID 0856260033, Serial Number 21107; UDI/DI N/A, System ID 0856260034, Serial Number 21096; UDI/DI N/A, System ID 06007NUC19, Serial Number 21091; UDI/DI N/A, System ID 06135NUC01, Serial Number 22262; UDI/DI N/A, System ID 34009NUC02, Serial Number 21320; UDI/DI N/A, System ID 34363NUC01, Serial Number 22128; UDI/DI N/A, System ID 34393NUC02, Serial Number 22254; UDI/DI N/A, System ID 34009NUC01, Serial Number 22305; UDI/DI N/A, System ID 34393NUC01, Serial Number 26072/25071; UDI/DI N/A, System ID 00361NUC08, Serial Number 21010; UDI/DI N/A, System ID 00052NUC11, Serial Number 22028; UDI/DI N/A, System ID 00234NUC09, Serial Number 21176; UDI/DI N/A, System ID 00271NUC07, Serial Number 21192; UDI/DI N/A, System ID 00271NUC10, Serial Number 22100; UDI/DI N/A, System ID 00439NUC12, Serial Number 21281; UDI/DI N/A, System ID 00242NUC06, Serial Number 21234; UDI/DI N/A, System ID 00242NUC08, Serial Number 22177; UDI/DI N/A, System ID 00001NUC12, Serial Number 21084; UDI/DI N/A, System ID 00001NUC11, Serial Number 22015; UDI/DI N/A, System ID 00001NUC20, Serial Number 22180; UDI/DI N/A, System ID 00310NUC06, Serial Number 21225; UDI/DI N/A, System ID 00123NUC01, Serial Number 21133; UDI/DI N/A, System ID 00258NUC02, Serial Number 21174; UDI/DI N/A, System ID 00197NUC14, Serial Number 21108; UDI/DI N/A, System ID 00199NUC21, Serial Number 21272; UDI/DI N/A, System ID 00149NUC03, Serial Number 21208; UDI/DI N/A, System ID 00149NUC01, Serial Number 21227; UDI/DI N/A, System ID 00162NUC11, Serial Number 26017/25015; UDI/DI N/A, System ID 00441NUC02, Serial Number 26062/25067; UDI/DI N/A, System ID 00065NUC08, Serial Number 21046; UDI/DI N/A, System ID 00203NUC06, Serial Number 26019/25021; UDI/DI N/A, System ID 00318NUC16, Serial Number 21293; UDI/DI N/A, System ID 10344NUC01, Serial Number 22241; UDI/DI N/A, System ID 10497NUC20, Serial Number 21043; UDI/DI N/A, System ID 00028NUC01, Serial Number 21051; UDI/DI N/A, System ID 11018NUC08, Serial Number 21120; UDI/DI N/A, System ID 10692NUC01, Serial Number 21301; UDI/DI N/A, System ID 00432NUC02, Serial Number 21124; UDI/DI N/A, System ID 00046NUC06, Serial Number 21027; UDI/DI N/A, System ID 00133NUC36, Serial Number 26048/25046; UDI/DI NA, System ID 905420BRIVO, Serial Number 24060; UDI/DI NA, System ID 306766D670, Serial Number 21236/28009.
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Recalling Firm/ Manufacturer |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel
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| 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 | 859 units |
| Distribution | Worldwide |
| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = KPS
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