Recall archive / FDA device enforcement
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) ... — FDA record Z-0891-2025
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/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
- 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
- 859 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0891-2025
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) 5376204-70-54-2: 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... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
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.