Recall archive / FDA device enforcement
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100J... — FDA record Z-0890-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Quantity
- 704 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0890-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 , Sys... |
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Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 22, 2025
- Recall initiation date
- Dec 18, 2024
- Center classification date
- Jan 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.