| 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-0890-2025 |
Recall Event ID |
96079 |
510(K)Number | K111445 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
|
Product | GE Healthcare Discovery NM 630, Model/Catalog Numbers:
1) 5376204-30-2,
2) H2401CF,
3) H2401CH,
4) H2401JE,
5) H3100JY; System, Tomography, Computed, Emission |
Code Information |
1) 5376204-30-2: UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0; UDI/DI N/A, System ID NT3061, Serial Number T2BG1600029/ 147600HL1; UDI/DI N/A, System ID NT3111, Serial Number 147243HL0; UDI/DI N/A, System ID NT3072, Serial Number 151822HL4; UDI/DI N/A, System ID NT3081, Serial Number T2BG1700045/ 155928HL5; UDI/DI N/A, System ID NT3080, Serial Number T2BG1700042/ 155272HL8; UDI/DI N/A, System ID NT3098, Serial Number T2BG1700051/ 158839HL1; UDI/DI N/A, System ID NT3088, Serial Number T2BG1700048/ 157050HL6; UDI/DI N/A, System ID NT3073, Serial Number T2BG1700040/ 150067HL7; UDI/DI N/A, System ID NT3076, Serial Number 153537HL6; UDI/DI N/A, System ID NT3048, Serial Number 141262HL6; UDI/DI N/A, System ID NT3083, Serial Number T2BG1700049/ 158144HL6; UDI/DI N/A, System ID NT0003, Serial Number T2AG14033/ 108281HL7; UDI/DI N/A, System ID NT3064, Serial Number T2BG1600025/ 146380HL1; UDI/DI N/A, System ID NT3082, Serial Number T2BG1700047/ 156900HL3; UDI/DI N/A, System ID NT3057, Serial Number T2BG1600022/ 146064HL1; UDI/DI N/A, System ID NT0005, Serial Number T2AG14040/ 119081HL8; UDI/DI N/A, System ID NT3054, Serial Number T2BG1600019/ 144873HL7; UDI/DI N/A, System ID NT3070, Serial Number T2BG1600024/ 146363HL7; UDI/DI N/A, System ID NT3067, Serial Number T2BG1600031/ 148143HL1; UDI/DI N/A, System ID NT3068, Serial Number T2BG1600034/ 149490HL5; UDI/DI N/A, System ID NT3063, Serial Number T2BG1600030/ 147951HL8; UDI/DI N/A, System ID NT3062, Serial Number T2BG1600033/ 148956HL6; UDI/DI N/A, System ID NT3056, Serial Number T2BG1600020/ 145513HL8; UDI/DI N/A, System ID NT1018, Serial Number T2AG13032/ 107349HL3; UDI/DI N/A, System ID NT3078, Serial Number T2BG1700043/ 155484HL9; UDI/DI N/A, System ID NT3089, Serial Number T2BG1800001/ 159887HL9; UDI/DI N/A, System ID NT3065, Serial Number T2BG1600032/ 148379HL1; UDI/DI N/A, System ID NT3085, Serial Number T2BG1700052/ 158907HL6; UDI/DI N/A, System ID NT3074, Serial Number T2BG1700039/ 151143HL5; UDI/DI N/A, System ID NT3049, Serial Number T2BG1600018/ 144093HL2; UDI/DI N/A, System ID NT3079, Serial Number 155785HL9.
2) H2401CF: UDI/DI N/A, System ID 83178091150, Serial Number T2BG1800006/165346HL8; UDI/DI N/A, System ID 083026248205316, Serial Number T2BG16006/135185HL7; UDI/DI N/A, System ID 083026865200717, Serial Number T2BG1600026/146941HL0; UDI/DI N/A, System ID 083026864251917, Serial Number T2BG1700036/148957HL4; UDI/DI N/A, System ID 083026820179816, Serial Number T2BG16007/191BH7; UDI/DI N/A, System ID 083026000641916, Serial Number T2BG1600008/194BH1; UDI/DI N/A, System ID 5512MI0002, Serial Number T2BG1600021/208BH9; UDI/DI N/A, System ID NT3052, Serial Number T2BG1600013/141857HL3; UDI/DI N/A, System ID NT3076, Serial Number T2BG1700041/153537HL6; UDI/DI N/A, System ID NT3069, Serial Number T2BG1700038/150128HL7; UDI/DI N/A, System ID NT3071, Serial Number T2BG1600014/142225HL2; UDI/DI N/A, System ID NT3086, Serial Number T2BG1800002/ ; UDI/DI N/A, System ID NT3090, Serial Number T2BG1700044/ ; UDI/DI N/A, System ID NT3060, Serial Number T2BG1600027/147230HL7; UDI/DI N/A, System ID Not Available, Serial Number T2BG1800005/253BH5; UDI/DI N/A, System ID Not Available, Serial Number T2BG1800008/261BH8; UDI/DI N/A, System ID NT8001, Serial Number T2BG1800007/ ; UDI/DI N/A, System ID NT3087, Serial Number T2BG1800003/ 23214; UDI/DI N/A, System ID Not Available, Serial Number T2BG1600010; UDI/DI N/A, System ID Not Available, Serial Number T2BG1600011; UDI/DI N/A, System ID Not Available, Serial Number T2BG1600012; UDI/DI N/A, System ID Not Available, Serial Number T2BG1600015; UDI/DI N/A, System ID Not Available, Serial Number T2BG1600016; UDI/DI N/A, System ID Not Available, Serial Number T2BG1600017; UDI/DI N/A, System ID Not Available, Serial Number T2BG1600028; UDI/DI N/A, System ID Not Available, Serial Number T2BG1700037.
3) H2401CH: UDI/DI N/A, System ID DZ1035NM06, Serial Number T26G16021/133975HL3; UDI/DI N/A, System ID DZ1035NM06, Serial Number T26G16020/133975HL3; UDI/DI N/A, System ID DZ1820NM01, Serial Number NT26G1800008; UDI/DI N/A, System ID DZ1060NM02, Serial Number T26G16023/135745HL8; UDI/DI N/A, System ID DZ2763NM02, Serial Number T26G1700043/157426HL8; UDI/DI N/A, System ID DZ2763NM01, Serial Number T26G1700044/157506HL7; UDI/DI N/A, System ID DZ1863NM01, Serial Number T26G1700042/156506HL8; UDI/DI N/A, System ID Not Available, Serial Number NT26G1800001; UDI/DI N/A, System ID Not Available, Serial Number T26G1600035/147228HL1; UDI/DI N/A, System ID EG1238NM01, Serial Number T26G1600033/145547HL6; UDI/DI N/A, System ID EG1000NM01, Serial Number T26G1700036/148833HL7; UDI/DI N/A, System ID EG1116NM01, Serial Number NT26G1800002; UDI/DI N/A, System ID EG1911NM01, Serial Number T26G16024/136251HL6; UDI/DI N/A, System ID EG2646NM01, Serial Number NT26G1800003; UDI/DI N/A, System ID EG1524NM01, Serial Number NT26G1800013; UDI/DI N/A, System ID EG2577NM01, Serial Number T26G1600031/136767HL1; UDI/DI N/A, System ID EG2577NM01, Serial Number T26G1600034/136767HL1; UDI/DI N/A, System ID IR2450NM01, Serial Number NT26G1800012; UDI/DI N/A, System ID Not Available, Serial Number T26G1700041/156108HL3; UDI/DI N/A, System ID NT3053, Serial Number 204BH8; UDI/DI N/A, System ID NT3051, Serial Number 197BH4; UDI/DI N/A, System ID KW1011NM01, Serial Number T26G16022/135526HL2; UDI/DI N/A, System ID KW1008NM01, Serial Number T26G1700038/152744HL9; UDI/DI N/A, System ID KW1008NM02, Serial Number T26G1700039/153170HL6; UDI/DI N/A, System ID KW1005NM09, Serial Number T26G1600027/0; UDI/DI N/A, System ID KW1005NM14, Serial Number T26G1600028/0; UDI/DI N/A, System ID KW1005NM11, Serial Number T26G1600029/144952HL9; UDI/DI N/A, System ID KW1005NM12, Serial Number T26G1600030/144953HL7; UDI/DI N/A, System ID Not Available, Serial Number NT26G1800004; UDI/DI N/A, System ID Not Available, Serial Number T26G1800002/160222HL6; UDI/DI N/A, System ID Not Available, Serial Number T26G16025; UDI/DI N/A, System ID Not Available, Serial Number T26G1600026; UDI/DI N/A, System ID Not Available, Serial Number T26G1600032; UDI/DI N/A, System ID Not Available, Serial Number T26G1700037/152214HL3; UDI/DI N/A, System ID PK1548NM01, Serial Number T26G1700040/155213HL2; UDI/DI N/A, System ID PK1035NM03, Serial Number NT26G1800009; UDI/DI N/A, System ID SA2706NM01, Serial Number NT26G1800011; UDI/DI N/A, System ID SA1013MN03, Serial Number T26G1800001/159471HL2; UDI/DI N/A, System ID TN1010NM01, Serial Number T26G1800003/160225HL9; UDI/DI N/A, System ID Not Available, Serial Number NT26G1800010; UDI/DI N/A, System ID AE1015NM01, Serial Number T26G15018/130763HL6; UDI/DI N/A, System ID AE1015NM02, Serial Number T26G15019/130992HL1; UDI/DI N/A, System ID Not Available, Serial Number NT26G1800005.
4) H2401JE: UDI/DI 84068212376, System ID 806665NM630, Serial number NT2GG1800001; UDI/DI N/A, System ID Not Available, Serial number T2GG1700002/150684HL9; UDI/DI N/A, System ID NT3084, Serial number T2BG1700050/ 246BH9.
5) H3100JY: UDI/DI (00840682115292, System ID 34443NUC01, Serial Number 630V22610; UDI/DI (00840682115292, System ID 34465NUC01, Serial Number 630V22611; UDI/DI (00840682115292, System ID 25015NUC01, Serial Number 630V22613; UDI/DI (00840682115292, System ID 34433NUC01, Serial Number 630V22614; UDI/DI (00840682115292, System ID 33044NUC01, Serial Number 630V22618; UDI/DI (00840682115292, System ID 33044NUC02, Serial Number 630V22619; UDI/DI (00840682115292, System ID 0850260155, Serial Number 630V22634; UDI/DI (00840682115292, System ID ZA2876NM01, Serial Number 630V22635; UDI/DI (00840682115292, System ID NM630V22636, Serial Number 630V22636; UDI/DI (00840682115292, System ID 00318NUC24, Serial Number 630V22643; UDI/DI (00840682115292, System ID Not Available, Serial Number 630V22645; UDI/DI (00840682115292, System ID 27031NUC01, Serial Number 630V22650; UDI/DI (00840682115292, System ID 240964D630C, Serial Number 630V22657; UDI/DI (00840682115292, System ID 804541NM630, Serial Number 630V22666; UDI/DI (00840682115292, System ID 00133NUC39, Serial Number 630V22673; UDI/DI (00840682115292, System ID 6073MI0007, Serial Number 630V22678; UDI/DI (00840682115292, System ID NM5506HN, Serial Number 630V22679; UDI/DI (00840682115292, System ID FE416078, Serial Number 630V22682; UDI/DI (00840682115292, System ID FEB34261, Serial Number 630V22683; UDI/DI (00840682115292, System ID 77257NUC01, Serial Number 630V22687; UDI/DI (00840682115292, System ID ZA2937NM01, Serial Number 630V22691; UDI/DI (00840682115292, System ID 55001NUC02, Serial Number 630V22692; UDI/DI (00840682115292, System ID 1573MI0006, Serial Number 630V22693; UDI/DI (00840682115292, System ID AH4001NU03, Serial Number 630V22701; UDI/DI (00840682115292, System ID Not Available, Serial Number 630V22702; UDI/DI (00840682115292, System ID NM630V22705, Serial Number 630V22705; UDI/DI (00840682115292, System ID MPX57811, Serial Number 630W22724; UDI/DI (00840682115292, System ID NM630W22737, Serial Number 630W22737; UDI/DI (00840682115292, System ID 0850260159, Serial Number 630W22742; UDI/DI (00840682115292, System ID A5333077, Serial Number 630W22747; UDI/DI (00840682115292, System ID 915839NU02, Serial Number 630W22749; UDI/DI (00840682115292, System ID 0850260160, Serial Number 630W22765; UDI/DI (00840682115292, System ID 00318NUC24, Serial Number 630W22771; UDI/DI (00840682115292, System ID 0850260161, Serial Number 630W22780; UDI/DI (00840682115292, System ID NT3075, Serial Number 630W22781; UDI/DI (00840682115292, System ID Not Available, Serial Number 630W22783; UDI/DI (00840682115292, System ID NM7100AR, Serial Number 630W22791; UDI/DI (00840682115292, System ID 01052NUC01, Serial Number 630W22803; UDI/DI (00840682115292, System ID C21952114, Serial Number 630W22804; UDI/DI (00840682115292, System ID UC1220NU03, Serial Number 630W22808; UDI/DI (00840682115292, System ID NM630W22810, Serial Number 630W22810; UDI/DI (00840682115292, System ID M1279756, Serial Number 630W22812; UDI/DI (00840682115292, System ID NM9891AR, Serial Number 630W22813; UDI/DI (00840682115292, System ID 772332NU04, Serial Number 630W22819; UDI/DI (00840682115292, System ID NM630W22828, Serial Number 630W22828; UDI/DI (00840682115292, System ID NM630W22834, Serial Number 630W22834; UDI/DI (00840682115292, System ID IE1038NM01, Serial Number 630W22835; UDI/DI (00840682115292, System ID NM630W22836, Serial Number 630W22836; UDI/DI (00840682115292, System ID M1804916, Serial Number 630W22844; UDI/DI (00840682115292, System ID NM5847AR, Serial Number 630W22847; UDI/DI (00840682115292, System ID 00019NUC01, Serial Number 630W22853; UDI/DI (00840682115292, System ID 150017NU10, Serial Number 630W22864; UDI/DI (00840682115292, System ID 0850260163, Serial Number 630W22867; UDI/DI (00840682115292, System ID 63022NUC01, Serial Number 630X22869; UDI/DI (00840682115292, System ID NM630X22877, Serial Number 630X22877; UDI/DI (00840682115292, System ID 35076NUC01, Serial Number 630X22881; UDI/DI (00840682115292, System ID 06184NUC03, Serial Number 630X22884; UDI/DI (00840682115292, System ID 0850260164, Serial Number 630X22885; UDI/DI (00840682115292, System ID NM5000CO, Serial Number 630X22888; UDI/DI (00840682115292, System ID NM630X22895, Serial Number 630X22895; UDI/DI (00840682115292, System ID 123285NU01, Serial Number 630X22899; UDI/DI (00840682115292, System ID NM8797CO, Serial Number 630X22900; UDI/DI (00840682115292, System ID CS1344NM02, Serial Number 630X22902; UDI/DI (00840682115292, System ID 00262NUC09, Serial Number 630X22908; UDI/DI (00840682115292, System ID NM9297AR, Serial Number 630X22909; UDI/DI (00840682115292, System ID B215175009, Serial Number 630X22920; UDI/DI (00840682115292, System ID UESS01NU03, Serial Number 630X22924; UDI/DI N/A , System ID 907276NM, Serial Number 630W22782; UDI/DI N/A , System ID 251368D630, Serial Number 630V22688; UDI/DI N/A , System ID 205481NM1, Serial Number 22375; UDI/DI N/A , System ID 205481NM2, Serial Number 22376; UDI/DI N/A , System ID UAB630, Serial Number 22363; UDI/DI N/A , System ID AM16R2Y781, Serial Number 22466; UDI/DI N/A , System ID 334793DISC2, Serial Number 22558; UDI/DI N/A , System ID 256768NM2, Serial Number 630X22898; UDI/DI N/A , System ID 256768NM3, Serial Number 630X22892; UDI/DI N/A , System ID 256768NM1, Serial Number 630X22883; UDI/DI N/A , System ID 256429NMGD1, Serial Number 22481; UDI/DI N/A , System ID 256265NM1, Serial Number 630W22831; UDI/DI N/A , System ID 256265NM, Serial Number 630W22815; UDI/DI N/A , System ID 334288NM, Serial Number 630W22837; UDI/DI N/A , System ID DCH630, Serial Number 22424; UDI/DI N/A , System ID 479754N630, Serial Number 630W22739; UDI/DI N/A , System ID 479441N630, Serial Number 22383; UDI/DI N/A , System ID 501552D630, Serial Number 630V22704; UDI/DI N/A , System ID 479338MB630, Serial Number 630V22663; UDI/DI N/A , System ID 479338N630, Serial Number 22422; UDI/DI N/A , System ID 928757NM, Serial Number 630V22632; UDI/DI N/A , System ID 928757NM, Serial Number 22384; UDI/DI N/A , System ID 623524D630, Serial Number 22594; UDI/DI N/A , System ID 661MTNM630, Serial Number 22317; UDI/DI N/A , System ID 310657D630, Serial Number 630X22925; UDI/DI N/A , System ID 510264D630, Serial Number 22526; UDI/DI N/A , System ID 562826D670NM, Serial Number 22489; UDI/DI N/A , System ID Not Available, Serial Number 22434; UDI/DI N/A , System ID RADNETNM176, Serial Number 630X22921; UDI/DI N/A , System ID 619543NM630, Serial Number 630W22740; UDI/DI N/A , System ID 408559D630, Serial Number 630W22798; UDI/DI N/A , System ID 805739D630, Serial Number 22578; UDI/DI N/A , System ID 707576D630, Serial Number 630W22726; UDI/DI N/A , System ID RADNETNM174, Serial Number 630V22717; UDI/DI N/A , System ID 661253NMD630, Serial Number 22532; UDI/DI N/A , System ID 818676NMD630, Serial Number 630V22674; UDI/DI N/A , System ID 303SJHD630, Serial Number 22356; UDI/DI N/A , System ID Not Available, Serial Number 22537; UDI/DI N/A , System ID 970BANNERD630, Serial Number 22374; UDI/DI N/A , System ID 970CPMCD630, Serial Number 22354; UDI/DI N/A , System ID 970MCKEED630, Serial Number 22483; UDI/DI N/A , System ID 719846NMH, Serial Number 630V22707; UDI/DI N/A , System ID 860224D630, Serial Number 630W22811; UDI/DI N/A , System ID 860489D630, Serial Number 630X22874; UDI/DI N/A , System ID 203452D630, Serial Number 630X22914; UDI/DI N/A , System ID 202444NM630, Serial Number 630W22818; UDI/DI N/A , System ID 302744NUC630, Serial Number 630W22850; UDI/DI N/A , System ID 727398D630A, Serial Number 22410; UDI/DI N/A , System ID 727398D630B, Serial Number 22482; UDI/DI N/A , System ID 727398D630C, Serial Number 22495; UDI/DI N/A , System ID LEEVANM630, Serial Number 22551; UDI/DI N/A , System ID 352265D630, Serial Number 22560; UDI/DI N/A , System ID 352265D670, Serial Number 22583; UDI/DI N/A , System ID 904296NM, Serial Number 630X22923; UDI/DI N/A , System ID 904296DISC, Serial Number 630X22894; UDI/DI N/A , System ID 904202DSC1, Serial Number 22517; UDI/DI N/A , System ID 904399DSC1, Serial Number 22541; UDI/DI N/A , System ID 904202DSC1, Serial Number 22566; UDI/DI N/A , System ID 904202DSC2, Serial Number 22588; UDI/DI N/A , System ID 386719D6301, Serial Number 630W22806; UDI/DI N/A , System ID 305575NMD630, Serial Number 630W22863; UDI/DI N/A , System ID AM13UMM430, Serial Number 22515; "UDI/DI N/A , System ID 239NHINM630, Serial Number 630W22755; "UDI/DI N/A , System ID 863824NM, Serial Number 630V22652; UDI/DI N/A , System ID OVI630, Serial Number 630V22633; UDI/DI N/A , System ID 630W22768, Serial Number 630W22768; UDI/DI N/A , System ID 941629NM, Serial Number 630W22773; UDI/DI N/A , System ID 772HFNM630, Serial Number 22496; UDI/DI N/A , System ID 813302D630, Serial Number 630V22694; UDI/DI N/A , System ID 813634D630, Serial Number 22431; UDI/DI N/A , System ID 850325D630, Serial Number 22462; UDI/DI N/A , System ID LMISMTV630, Serial Number 630W22851; UDI/DI N/A , System ID 727834D630, Serial Number 22367; UDI/DI N/A , System ID 772562NM, Serial Number 630W22825; UDI/DI N/A , System ID 561798D630, Serial Number 630W22738; UDI/DI N/A , System ID 561844D630, Serial Number 630V22639; UDI/DI N/A , System ID 706481NUC, Serial Number 22331; UDI/DI N/A , System ID 706481NUC, Serial Number 22545; UDI/DI N/A , System ID 770732D630, Serial Number 630V22648; UDI/DI N/A , System ID AM16R5V485, Serial Number 22396; UDI/DI N/A , System ID 404501D630, Serial Number 630V22653; UDI/DI N/A , System ID 478275NM2, Serial Number 630X22875; UDI/DI N/A , System ID 478275NM1, Serial Number 630X22872; UDI/DI N/A , System ID 706787NM2, Serial Number 630W22767; UDI/DI N/A , System ID 706787NM1, Serial Number 630W22759; UDI/DI N/A , System ID 912530NM, Serial Number 630W22736; UDI/DI N/A , System ID 706845WG630, Serial Number 22446; UDI/DI N/A , System ID 478633D630, Serial Number 22559; UDI/DI N/A , System ID 770793D630, Serial Number 630V22621; UDI/DI N/A , System ID 770793D630B, Serial Number 630X22906; UDI/DI N/A , System ID 208359D630, Serial Number 630W22849; UDI/DI N/A , System ID 773967NM630, Serial Number 630V22690; UDI/DI N/A , System ID 773626NM630, Serial Number 630V22615; UDI/DI N/A , System ID 773296D630, Serial Number 22361; UDI/DI N/A , System ID 217876NM630, Serial Number 22398; UDI/DI N/A , System ID 847570NM630, Serial Number 630X22896; UDI/DI N/A , System ID 847990NM640, Serial Number 22351; UDI/DI N/A , System ID 618997NM1, Serial Number 630V22716; UDI/DI N/A , System ID 618997NM, Serial Number 630W22729; UDI/DI N/A , System ID 217258NUC1, Serial Number 22584; UDI/DI N/A , System ID 815942NM630, Serial Number 630V22700; UDI/DI N/A , System ID 630527NM6302, Serial Number 22568; UDI/DI N/A , System ID 630527NM630, Serial Number 22569; UDI/DI N/A , System ID 708660NM630, Serial Number 22521; UDI/DI N/A , System ID 708660NM630, Serial Number 22562; UDI/DI N/A , System ID 847723NM630, Serial Number 630V22667; UDI/DI N/A , System ID 217285D630, Serial Number 630V22612; UDI/DI N/A , System ID 1000001078, Serial Number 630W22800; UDI/DI N/A , System ID 765649NM2, Serial Number 630W22862; UDI/DI N/A , System ID 765649NM, Serial Number 630W22761; UDI/DI N/A , System ID 812450NM630, Serial Number 22543; UDI/DI N/A , System ID 317355NM, Serial Number 630W22779; UDI/DI N/A , System ID 317355D630, Serial Number 22437; UDI/DI N/A , System ID 765453NM, Serial Number 630W22750; UDI/DI N/A , System ID 812537D630, Serial Number 22327; UDI/DI N/A , System ID 574753D630, Serial Number 22445; UDI/DI N/A , System ID 812949D6302, Serial Number 630V22660; UDI/DI N/A , System ID 812883D630, Serial Number 22329; UDI/DI N/A , System ID 812238D6302, Serial Number 630W22792; UDI/DI N/A , System ID 812238D6301, Serial Number 630W22790; UDI/DI N/A , System ID 620272NM, Serial Number 630W22746; UDI/DI N/A , System ID 620669D630, Serial Number 630W22843; UDI/DI N/A , System ID PRATTD6301, Serial Number 22336; UDI/DI N/A , System ID RUSSELLD630, Serial Number 630V22651; UDI/DI N/A , System ID AM13BIT314, Serial Number 22463; UDI/DI N/A , System ID 270692D630, Serial Number 630W22827; UDI/DI N/A , System ID 270692D630, Serial Number 630W22824; UDI/DI N/A , System ID 606789D630, Serial Number 22484; UDI/DI N/A , System ID 859987D630, Serial Number 22380; UDI/DI N/A , System ID 859745D630, Serial Number 630V22662; UDI/DI N/A , System ID 318448D630RM2, Serial Number 22518; UDI/DI N/A , System ID 225755D630, Serial Number 22564; UDI/DI N/A , System ID 225755D630, Serial Number 22593; UDI/DI N/A , System ID 504392D630, Serial Number 630V22641; UDI/DI N/A , System ID 337261D630, Serial Number 22318; UDI/DI N/A , System ID 337289D630, Serial Number 22435; UDI/DI N/A , System ID 504896D630, Serial Number 630W22833; UDI/DI N/A , System ID 508771630_2, Serial Number 630V22686; UDI/DI N/A , System ID 508771630, Serial Number 22524; UDI/DI N/A , System ID 508961630, Serial Number 22486; UDI/DI N/A , System ID 410328NMD630, Serial Number 630V22668; UDI/DI N/A , System ID 410933NM, Serial Number 630X22907; UDI/DI N/A , System ID 410350NM1, Serial Number 630W22832; UDI/DI N/A , System ID 410350NM, Serial Number 630W22793; UDI/DI N/A , System ID 410328NM, Serial Number 630W22763; UDI/DI N/A , System ID 240964D630C, Serial Number 630W22754; UDI/DI N/A , System ID 301475D630, Serial Number 22509; UDI/DI N/A , System ID 410414OPT640, Serial Number 22609; UDI/DI N/A , System ID 410362D630, Serial Number 630W22762; UDI/DI N/A , System ID 410521O640, Serial Number 22460; UDI/DI N/A , System ID 240314D670NM, Serial Number 22520; UDI/DI N/A , System ID 240637D630, Serial Number 630W22769; UDI/DI N/A , System ID 231592D630, Serial Number 22501; UDI/DI N/A , System ID 517279D630, Serial Number 630V22695; UDI/DI N/A , System ID 313343D630, Serial Number 22591; UDI/DI N/A , System ID 810329D630, Serial Number 22546; UDI/DI N/A , System ID 810329D630, Serial Number 22572; UDI/DI N/A , System ID 1000000606, Serial Number 22417; UDI/DI N/A , System ID 616847D630, Serial Number 22339; UDI/DI N/A , System ID 269226D630, Serial Number 22433; UDI/DI N/A , System ID 231845D630, Serial Number 22459; UDI/DI N/A , System ID 269781D630, Serial Number 630W22838; UDI/DI N/A , System ID 734N1, Serial Number 22561; UDI/DI N/A , System ID 269687D630, Serial Number 630W22748; UDI/DI N/A , System ID 989453D630, Serial Number 22530; UDI/DI N/A , System ID 989453D630, Serial Number 22533; UDI/DI N/A , System ID 269983D630, Serial Number 630V22719; UDI/DI N/A , System ID 269659D630, Serial Number 22432; UDI/DI N/A , System ID 313295D630, Serial Number 22597; UDI/DI N/A , System ID 734246D630, Serial Number 22458; UDI/DI N/A , System ID 507385NM2, Serial Number 630W22785; UDI/DI N/A , System ID 507385NM, Serial Number 630W22751; UDI/DI N/A , System ID 651254DSC630, Serial Number 22373; UDI/DI N/A , System ID 651430NM630, Serial Number 630X22890; UDI/DI N/A , System ID 417556D631, Serial Number 22325; UDI/DI N/A , System ID 573632D630, Serial Number 22428; UDI/DI N/A , System ID 417556D632, Serial Number 22335; UDI/DI N/A , System ID 816276D630, Serial Number 630V22712; UDI/DI N/A , System ID 417354D630, Serial Number 630W22858; UDI/DI N/A , System ID 314525D630, Serial Number 22326; UDI/DI N/A , System ID 417256D630B, Serial Number 630X22870; UDI/DI N/A , System ID 601645D630, Serial Number 22412; UDI/DI N/A , System ID 662846D630, Serial Number 630W22820; UDI/DI N/A , System ID 601364D630C32C, Serial Number 630V22709; UDI/DI N/A , System ID 601364D630C29, Serial Number 630V22670; UDI/DI N/A , System ID 601364D630CB37, Serial Number 630V22638; UDI/DI N/A , System ID 601968D630, Serial Number 22328; UDI/DI N/A , System ID 601249D630, Serial Number 630W22772; UDI/DI N/A , System ID 662932OBD630, Serial Number 22500; UDI/DI N/A , System ID 406657BC630, Serial Number 22350; UDI/DI N/A , System ID 406414NM, Serial Number 630V22710; UDI/DI N/A , System ID 919575D630, Serial Number 22454; UDI/DI N/A , System ID JC630, Serial Number 22311; UDI/DI N/A , System ID 919286GE630A, Serial Number 630W22859; UDI/DI N/A , System ID 919684CC630, Serial Number 630W22777; UDI/DI N/A , System ID 919286GED630, Serial Number 22492; UDI/DI N/A , System ID AM13DC2230, Serial Number 22477; UDI/DI N/A , System ID 828696D630, Serial Number 22453; UDI/DI N/A , System ID SM630, Serial Number 630V22637; UDI/DI N/A , System ID MHMD828GENM01, Serial Number 630V22656; UDI/DI N/A , System ID FHR630, Serial Number 630W22725; UDI/DI N/A , System ID 919784D630, Serial Number 22461; UDI/DI N/A , System ID 704638D630, Serial Number 630W22745; UDI/DI N/A , System ID 701857D630, Serial Number 22429; UDI/DI N/A , System ID 402481OPT640, Serial Number 630W22735; UDI/DI N/A , System ID 402486D630, Serial Number 22441; UDI/DI N/A , System ID 402451D640, Serial Number 22587; UDI/DI N/A , System ID 603742NM630, Serial Number 630W22807; UDI/DI N/A , System ID 908994D630B, Serial Number 630W22786; UDI/DI N/A , System ID 908994D630A, Serial Number 630W22752; UDI/DI N/A , System ID 201894D630, Serial Number 22316; UDI/DI N/A , System ID 732294D630, Serial Number 630V22671; UDI/DI N/A , System ID 201795D630, Serial Number 630W22733; UDI/DI N/A , System ID 973971D630, Serial Number 22385; UDI/DI N/A , System ID 973926D630, Serial Number 630W22743; UDI/DI N/A , System ID 732381D630, Serial Number 22457; UDI/DI N/A , System ID Not Available, Serial Number 22542; UDI/DI N/A , System ID 505863D630, Serial Number 630V22658; UDI/DI N/A , System ID 575522NM630, Serial Number 22359; UDI/DI N/A , System ID 575622NM, Serial Number 630V22689; UDI/DI N/A , System ID 575627NM, Serial Number 630V22665; UDI/DI N/A , System ID 575538NM, Serial Number 630W22734; UDI/DI N/A , System ID Not Available, Serial Number 22344; UDI/DI N/A , System ID 702731NUC1, Serial Number 22391; UDI/DI N/A , System ID 702731NUC1, Serial Number 22468; UDI/DI N/A , System ID 775WNKANM, Serial Number 22378; UDI/DI N/A , System ID 718267NMD630C1, Serial Number 22586; UDI/DI N/A , System ID 718960D630, Serial Number 630X22871; UDI/DI N/A , System ID 718579NMD630C1, Serial Number 22604; UDI/DI N/A , System ID 585798NMD630, Serial Number 630V22629; UDI/DI N/A , System ID 914666D630, Serial Number 630W22840; UDI/DI N/A , System ID RADNETNM1747, Serial Number 630W22728; UDI/DI N/A , System ID COR522690, Serial Number 22401; UDI/DI N/A , System ID COR522692, Serial Number 22402; UDI/DI N/A , System ID 631654D630, Serial Number 630V22628; UDI/DI N/A , System ID 631474D630, Serial Number 630V22706; UDI/DI N/A , System ID 516705NM630, Serial Number 630W22821; UDI/DI N/A , System ID 516562630D1, Serial Number 630V22708; UDI/DI N/A , System ID 716592NM, Serial Number 630W22830; UDI/DI N/A , System ID 718226NMD630, Serial Number 630V22642; UDI/DI N/A , System ID 718818NMD630B, Serial Number 630W22730; UDI/DI N/A , System ID 718818NM630, Serial Number 22312; UDI/DI N/A , System ID 914493D630, Serial Number 630W22839; UDI/DI N/A , System ID 914682D630, Serial Number 630W22845; UDI/DI N/A , System ID 330543D640, Serial Number 630X22889; UDI/DI N/A , System ID 740593D630, Serial Number 22602; UDI/DI N/A , System ID 513CCHB630, Serial Number 630X22876; UDI/DI N/A , System ID 513584NM630, Serial Number 630W22775; UDI/DI N/A , System ID 937431DIS, Serial Number 630W22857; UDI/DI N/A , System ID 419783NM, Serial Number 630X22917; UDI/DI N/A , System ID 419332NMD630, Serial Number 630V22675; UDI/DI N/A , System ID 419SLN1, Serial Number 22535; UDI/DI N/A , System ID 740393D630, Serial Number 22400; UDI/DI N/A , System ID 419BPN1, Serial Number 22397; UDI/DI N/A , System ID 419394630, Serial Number 22409; UDI/DI N/A , System ID 937523D6302, Serial Number 22480; UDI/DI N/A , System ID 937523D6301, Serial Number 22494; UDI/DI N/A , System ID Not Available, Serial Number 22353; UDI/DI N/A , System ID 419SAN1, Serial Number 22519; UDI/DI N/A , System ID 419WYN1, Serial Number 22579; UDI/DI N/A , System ID 937352D630, Serial Number 630V22647; UDI/DI N/A , System ID 918341NM, Serial Number 630V22703; UDI/DI N/A , System ID 918786NM1, Serial Number 22585; UDI/DI N/A , System ID 405628D630, Serial Number 630V22697; UDI/DI N/A , System ID 405303NM630, Serial Number 630W22756; UDI/DI N/A , System ID 918453NM2, Serial Number 630V22655; UDI/DI N/A , System ID 918453NM1, Serial Number 630V22624; UDI/DI N/A , System ID 918294NM, Serial Number 630V22654; UDI/DI N/A , System ID 580254D630, Serial Number 630V22659; UDI/DI N/A , System ID 541269D630, Serial Number 22595; UDI/DI N/A , System ID 814877D630, Serial Number 630W22865; UDI/DI N/A , System ID 412647D630R1, Serial Number 22322; UDI/DI N/A , System ID 570421NM, Serial Number 630V22623; UDI/DI N/A , System ID 803751NM4, Serial Number 22399; UDI/DI N/A , System ID 803791D630, Serial Number 22430; UDI/DI N/A , System ID 605322NM, Serial Number 630W22776; UDI/DI N/A , System ID Not Available, Serial Number 22372; UDI/DI N/A , System ID 423493NM630, Serial Number 630W22774; UDI/DI N/A , System ID 931381NM3, Serial Number 22608; UDI/DI N/A .System ID 615446NM630, Serial Number 22346; UDI/DI N/A , System ID 615328NM, Serial Number 630V22696; UDI/DI N/A , System ID 901516GD630NM3, Serial Number 630V22699; UDI/DI N/A , System ID 615744NM, Serial Number 630X22916; UDI/DI N/A , System ID 615338D630, Serial Number 22502; UDI/DI N/A , System ID 931815NUC, Serial Number 630W22778; UDI/DI N/A , System ID 901516UD630, Serial Number 630V22664; UDI/DI N/A , System ID 901516ND630NM3, Serial Number 630V22622; UDI/DI N/A , System ID 901226NMD630, Serial Number 630V22617; UDI/DI N/A , System ID 901516ND630, Serial Number 22485; UDI/DI N/A , System ID 423926NM1, Serial Number 22570; UDI/DI N/A , System ID 423926NM1, Serial Number 22581; UDI/DI N/A , System ID 615222NM, Serial Number 630W22757; UDI/DI N/A , System ID 865481NM630, Serial Number 630V22630; UDI/DI N/A , System ID 865545NM630, Serial Number 22580; UDI/DI N/A , System ID 865545NM630, Serial Number 22596; UDI/DI N/A , System ID 931363NUC, Serial Number 630W22814; UDI/DI N/A , System ID 931393NM2, Serial Number 22523; UDI/DI N/A , System ID 325428NM1, Serial Number 22552; UDI/DI N/A , System ID 806212NM630RM3, Serial Number 630W22801; UDI/DI N/A , System ID 806212NM630RM3, Serial Number 630W22796; UDI/DI N/A , System ID 817960NM630, Serial Number 22440; UDI/DI N/A , System ID 817472NM630, Serial Number 22512; UDI/DI N/A , System ID 512555NM, Serial Number 630V22711; UDI/DI N/A , System ID 817848NM, Serial Number 630V22640; UDI/DI N/A , System ID 817848NM630, Serial Number 22487; UDI/DI N/A , System ID 325646NMD630, Serial Number 22607; UDI/DI N/A , System ID 512528D630, Serial Number 22550; UDI/DI N/A , System ID 214857NM630A, Serial Number 22349; UDI/DI N/A , System ID 830775NM, Serial Number 630W22732; UDI/DI N/A , System ID 903416NMOPT1, Serial Number 22365; UDI/DI N/A , System ID 940384NM, Serial Number 630W22744; UDI/DI N/A , System ID 915577D630NM, Serial Number 630V22626; UDI/DI N/A , System ID 915521NM630, Serial Number 630V22625; UDI/DI N/A , System ID 915577NM630, Serial Number 22360; UDI/DI N/A , System ID 817702NM630, Serial Number 630X22891; UDI/DI N/A , System ID 817433DISC, Serial Number 630W22848; UDI/DI N/A , System ID 817335NM630, Serial Number 22405; UDI/DI N/A , System ID 972963NM, Serial Number 630W22809; UDI/DI N/A , System ID 409761NM2, Serial Number 630W22795; UDI/DI N/A , System ID 409761NM2, Serial Number 630W22794; UDI/DI N/A , System ID 409761NM3, Serial Number 630W22789; UDI/DI N/A , System ID Not Available, Serial Number 630V22714; UDI/DI N/A , System ID 713448D630RM3, Serial Number 630X22910; UDI/DI N/A , System ID 713440NM630, Serial Number 630X22880; UDI/DI N/A , System ID 713448D630RM2, Serial Number 630X22878; UDI/DI N/A , System ID 281295NM1, Serial Number 630X22873; UDI/DI N/A , System ID 713448D630RM1, Serial Number 630W22846; UDI/DI N/A , System ID 281333D630, Serial Number 630W22727; UDI/DI N/A , System ID Not Available, Serial Number 630V22616; UDI/DI N/A , System ID 972258NM630, Serial Number 630X22919; UDI/DI N/A , System ID 281644NUC, Serial Number 630W22817; UDI/DI N/A , System ID 806775NM3, Serial Number 22411; UDI/DI N/A , System ID 281PLMC630, Serial Number 22358; UDI/DI N/A , System ID 972596NM, Serial Number 630V22698; UDI/DI N/A , System ID 210297630D2, Serial Number 630V22672; UDI/DI N/A , System ID 210297630D1, Serial Number 630V22631; UDI/DI N/A , System ID 210736TEXSAN, Serial Number 22522; UDI/DI N/A , System ID 713897D630, Serial Number 630W22829; UDI/DI N/A , System ID 903614NUC, Serial Number 630W22764; UDI/DI N/A , System ID 361788NM630, Serial Number 630W22787; UDI/DI N/A , System ID 254741D630, Serial Number 22498; UDI/DI N/A , System ID 281338D630, Serial Number 22425; UDI/DI N/A , System ID 434295D630A, Serial Number 630V22722; UDI/DI N/A , System ID 434924DISCO, Serial Number 630W22856; UDI/DI N/A , System ID 434984NUC, Serial Number 630W22723; UDI/DI N/A , System ID 804435NM630, Serial Number 630W22760; UDI/DI N/A , System ID 804764D630C, Serial Number 630X22922; UDI/DI N/A , System ID 804594NM630, Serial Number 630W22823; UDI/DI N/A , System ID CLINCH630, Serial Number 630W22842; UDI/DI N/A , System ID 571367D630, Serial Number 22499; UDI/DI N/A , System ID 276228W630, Serial Number 630V22627; UDI/DI N/A , System ID 802334NM630, Serial Number 22307; UDI/DI N/A , System ID EC2NM630, Serial Number 630V22644; UDI/DI N/A , System ID ECNM630, Serial Number 22528; UDI/DI N/A , System ID JGHNM630, Serial Number 630V22715; UDI/DI N/A , System ID MGHNM630, Serial Number 630W22758; UDI/DI N/A , System ID 360744NUC630, Serial Number 630W22860; UDI/DI N/A , System ID 414805D630, Serial Number 630W22797; UDI/DI N/A , System ID Not Available, Serial Number 630W22722; UDI/DI N/A , System ID Not Available, Serial Number 630W22720; UDI/DI N/A , System ID Not Available, Serial Number 22573; UDI/DI N/A , System ID Not Available, Serial Number 22456; UDI/DI N/A , System ID Not Available, Serial Number 22443; UDI/DI N/A , System ID 608524D630, Serial Number 22493; UDI/DI N/A , System ID 304388D630, Serial Number 22338; UDI/DI N/A , System ID 304329D630, Serial Number 22436; UDI/DI N/A , System ID 307VACHEYD630, Serial Number 22565; UDI/DI N/A , System ID NM22574, Serial Number 22574; UDI/DI N/A , System ID NM22601, Serial Number 22601; UDI/DI N/A , System ID NM22539, Serial Number 22539; UDI/DI N/A , System ID NM22406, Serial Number 22406; UDI/DI N/A , System ID NM22348, Serial Number 22348; UDI/DI N/A , System ID 83136995971, Serial Number 22472; UDI/DI N/A , System ID 83136995971, Serial Number 22555; UDI/DI N/A , System ID 83120620287, Serial Number 22381; UDI/DI N/A , System ID AH0180NU01, Serial Number 22320; UDI/DI N/A , System ID 080038NU07, Serial Number 22536; UDI/DI N/A , System ID 080038NU07, Serial Number 22379; UDI/DI N/A , System ID 060055NU11, Serial Number 22563; UDI/DI N/A , System ID 040158NU08, Serial Number 22334; UDI/DI N/A , System ID NM22366XE, Serial Number 22366; UDI/DI N/A , System ID NM22470, Serial Number 22470; UDI/DI N/A , System ID NM22403, Serial Number 22403; UDI/DI N/A , System ID NM22510, Serial Number 22510; UDI/DI N/A , System ID NM22415, Serial Number 22415; UDI/DI N/A , System ID NM22357, Serial Number 22357; UDI/DI N/A , System ID Not Available, Serial Number 630W22721; UDI/DI N/A , System ID NM22540, Serial Number 22540; UDI/DI N/A , System ID NM22538, Serial Number 22538; UDI/DI N/A , System ID NM22314, Serial Number 22314; UDI/DI N/A , System ID NM22355, Serial Number 22355; UDI/DI N/A , System ID 204726D671, Serial Number 22450; UDI/DI N/A , System ID 905791D630, Serial Number 22448; UDI/DI N/A , System ID 905848D630, Serial Number 22337; UDI/DI N/A , System ID E416249D630B, Serial Number 22393; UDI/DI N/A , System ID E416249D630A, Serial Number 22394; UDI/DI N/A , System ID 905721D630, Serial Number 22438; UDI/DI N/A , System ID 416438D630, Serial Number 630X22905; UDI/DI N/A , System ID HANUCD630, Serial Number 630W22822; UDI/DI N/A , System ID 416534D630, Serial Number 22479; UDI/DI N/A , System ID 519735D630, Serial Number 630V22661; UDI/DI N/A , System ID Not Available, Serial Number 22476; UDI/DI N/A , System ID 819378D630, Serial Number 22504; UDI/DI N/A , System ID NM630X22868, Serial Number 630X22868; UDI/DI N/A , System ID 082426040076, Serial Number 630W22753; UDI/DI N/A , System ID 082426040056, Serial Number 22465; UDI/DI N/A , System ID 082426220010, Serial Number 630W22826; UDI/DI N/A , System ID 082426230027, Serial Number 22439; UDI/DI N/A , System ID 082426160057, Serial Number 630V22677; UDI/DI N/A , System ID 082426070037, Serial Number 22369; UDI/DI N/A , System ID 082426150043, Serial Number 630X22897; UDI/DI N/A , System ID 082426290009, Serial Number 22332; UDI/DI N/A , System ID 082426210025, Serial Number 22377; UDI/DI N/A , System ID 082426190030, Serial Number 22475; UDI/DI N/A , System ID 082426190033, Serial Number 630X22887; UDI/DI N/A , System ID 082426120029, Serial Number 22513; UDI/DI N/A , System ID 082426200013, Serial Number 22478; UDI/DI N/A , System ID 082426200012, Serial Number 22368; UDI/DI N/A , System ID 082426030030, Serial Number 22340; UDI/DI N/A , System ID 082426030034, Serial Number 630V22649; UDI/DI N/A , System ID 082426100070, Serial Number 22606; UDI/DI N/A , System ID 082426139007, Serial Number 630W22766; UDI/DI N/A , System ID 082426080027, Serial Number 630W22770; UDI/DI N/A , System ID 082426230030, Serial Number 630X22911; UDI/DI N/A , System ID 082426050014, Serial Number 630V22620; UDI/DI N/A , System ID NM22421, Serial Number 22421; UDI/DI N/A , System ID NM22315, Serial Number 22315; UDI/DI N/A , System ID NM22452, Serial Number 22452; UDI/DI N/A , System ID CS1021NM04, Serial Number 22345; UDI/DI N/A , System ID CS6096NM01, Serial Number 22529; UDI/DI N/A , System ID CS1341NM03, Serial Number 22592; UDI/DI N/A , System ID M4138007, Serial Number 22310; UDI/DI N/A , System ID M4163785, Serial Number 22514; UDI/DI N/A , System ID A2846906, Serial Number 22455; UDI/DI N/A , System ID V7417603, Serial Number 22362; UDI/DI N/A , System ID M2846913, Serial Number 22488; UDI/DI N/A , System ID 440719NU01, Serial Number 22390; UDI/DI N/A , System ID TP4447NU03, Serial Number 22464; UDI/DI N/A , System ID UC0841NU03, Serial Number 22395; UDI/DI N/A , System ID HC7643NU01, Serial Number 22321; UDI/DI N/A , System ID PC4206NU01, Serial Number 22507; UDI/DI N/A , System ID PC5307NU02, Serial Number 22364; UDI/DI N/A , System ID HC7196NU01, Serial Number 22467; UDI/DI N/A , System ID UC4398NU01, Serial Number 22567; UDI/DI N/A , System ID 144782NU02, Serial Number 22590; UDI/DI N/A , System ID 403590NU01, Serial Number 22414; UDI/DI N/A , System ID Not Available, Serial Number 22469; UDI/DI N/A , System ID H2075NUC06, Serial Number 22506; UDI/DI N/A , System ID 083026240158318, Serial Number 630X22913; UDI/DI N/A , System ID 083026826847518, Serial Number 630X22915; UDI/DI N/A , System ID 083026824012317, Serial Number 630W22866; UDI/DI N/A , System ID 083026823585515, Serial Number 22556; UDI/DI N/A , System ID 083026841505318, Serial Number 630W22784; UDI/DI N/A , System ID IL1495NM01, Serial Number 630X22879; UDI/DI N/A , System ID IL1505NM01, Serial Number 630W22788; UDI/DI N/A , System ID A343134105, Serial Number 22603; UDI/DI N/A , System ID A343134108, Serial Number 22605; UDI/DI N/A , System ID A5805542, Serial Number 22449; UDI/DI N/A , System ID A5632437, Serial Number 22534; UDI/DI N/A , System ID A5634716, Serial Number 22343; UDI/DI N/A , System ID NT3077, Serial Number 22503; UDI/DI N/A , System ID NT3034, Serial Number 22508; UDI/DI N/A , System ID NT3042, Serial Number 22548; UDI/DI N/A , System ID NT3022, Serial Number 22352; UDI/DI N/A , System ID NT3036, Serial Number 22525; UDI/DI N/A , System ID NT3025, Serial Number 22382; UDI/DI N/A , System ID NT3040, Serial Number 22416; UDI/DI N/A , System ID NT3047, Serial Number 22599; UDI/DI N/A , System ID NT3038, Serial Number 22531; UDI/DI N/A , System ID NT3045, Serial Number 22582; UDI/DI N/A , System ID NT3046, Serial Number 22589; UDI/DI N/A , System ID NT3044, Serial Number 22554; UDI/DI N/A , System ID NT3019, Serial Number 22319; UDI/DI N/A , System ID Not Available, Serial Number 630W22861; UDI/DI N/A , System ID NT3039, Serial Number 22313; UDI/DI N/A , System ID NT3037, Serial Number 22408; UDI/DI N/A , System ID NT3028, Serial Number 22420; UDI/DI N/A , System ID NT3066, Serial Number 22527; UDI/DI N/A , System ID NT3041, Serial Number 22549; UDI/DI N/A , System ID NT3031, Serial Number 22423; UDI/DI N/A , System ID NT3027, Serial Number 22388; UDI/DI N/A , System ID NT3026, Serial Number 22386; UDI/DI N/A , System ID NT3024, Serial Number 22371; UDI/DI N/A , System ID NT3055, Serial Number 22511; UDI/DI N/A , System ID NT3023, Serial Number 22370; UDI/DI N/A , System ID NT3032, Serial Number 22451; UDI/DI N/A , System ID NT3050, Serial Number 22497; UDI/DI N/A , System ID NT3035, Serial Number 22413; UDI/DI N/A , System ID NT3043, Serial Number 22309; UDI/DI N/A , System ID NT3043, Serial Number 22544; UDI/DI N/A , System ID NT3017, Serial Number 22324; UDI/DI N/A , System ID NT3016, Serial Number 22308; UDI/DI N/A , System ID NT3018, Serial Number 22330; UDI/DI N/A , System ID NT3029, Serial Number 22427; UDI/DI N/A , System ID 0850260146, Serial Number 22426; UDI/DI N/A , System ID 0850260149, Serial Number 22505; UDI/DI N/A , System ID 0850260144, Serial Number 22444; UDI/DI N/A , System ID 0850260139, Serial Number 22419; UDI/DI N/A , System ID 0850260153, Serial Number 22575; UDI/DI N/A , System ID 0850260152, Serial Number 22576; UDI/DI N/A , System ID 0850260151, Serial Number 22577; UDI/DI N/A , System ID Not Available, Serial Number 22407; UDI/DI N/A , System ID NO1087MN15, Serial Number 630W22841; UDI/DI N/A , System ID NM22447, Serial Number 22447; UDI/DI N/A , System ID PL1778NM01, Serial Number 22571; UDI/DI N/A , System ID PPR94119, Serial Number 22557; UDI/DI N/A , System ID PPS20802, Serial Number 22404; UDI/DI N/A , System ID NM22471, Serial Number 22471; UDI/DI N/A , System ID NM4193PR, Serial Number 630V22685; UDI/DI N/A , System ID RU6340NM02, Serial Number 630V22680; UDI/DI N/A , System ID RU6171NM01, Serial Number 630W22799; UDI/DI N/A , System ID 6073MI0001, Serial Number 22306; UDI/DI N/A , System ID ZA2158NM02, Serial Number 22474; UDI/DI N/A , System ID ZA2651NM01, Serial Number 22347; UDI/DI N/A , System ID ZA2766NM01, Serial Number 22516; UDI/DI N/A , System ID M001NU44, Serial Number 22389; UDI/DI N/A , System ID 900010NU13, Serial Number 22333; UDI/DI N/A , System ID 0853260161, Serial Number 630V22718; UDI/DI N/A , System ID 0853260143, Serial Number 22442; UDI/DI N/A , System ID 0853260139, Serial Number 22387; UDI/DI N/A , System ID 0853260156, Serial Number 630V22684; UDI/DI N/A , System ID 0853260133, Serial Number 22323; UDI/DI N/A , System ID 0853260195, Serial Number 630X22912; UDI/DI N/A , System ID 0853260172, Serial Number 630W22854; UDI/DI N/A , System ID 0853260168, Serial Number 630W22805; UDI/DI N/A , System ID 0853260179, Serial Number 630X22893; UDI/DI N/A , System ID 0853260182, Serial Number 630X22886; UDI/DI N/A , System ID 0853260188, Serial Number 630X22904; UDI/DI N/A , System ID 0853260192, Serial Number 630X22903; UDI/DI N/A , System ID 0853260136, Serial Number 22342; UDI/DI N/A , System ID 0853260185, Serial Number 630X22901; UDI/DI N/A , System ID 06184NUC08, Serial Number 630X22882; UDI/DI N/A , System ID 67021NUC01, Serial Number 22392. |
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 | 704 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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