Recall archive / FDA device enforcement
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH;... — FDA record Z-0893-2025
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 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; 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
- 283 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0893-2025
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 NT4011, Serial Number 131640HL5; UDI/DI N/A, System ID NT1023, Serial Number 154472HL5; UDI/DI N/A, System ID NT4003, Serial Number 128062HL7; UDI/DI N/A, System ID NT4005, Serial Number 128536HL0; UDI/DI N/A, System ID NT1022, Serial Number 154066HL5. 2) H2401AK: UDI/DI N/A, System ID 83131625480, Serial Number T27G15012/131277HL6; UDI/DI N/A, System ID 83119512125, Serial Number T2AG14038/0; UDI/DI N/A, System ID 83151204341, Serial Number T27G1600025/0; UDI/DI N/A, System ID 83153611901, Serial Number T27G1700030/147506HL0; UDI/DI N/A, System ID 83136989873, Serial Number T27G15006/GLX-TAN-03716; UDI/DI N/A, System ID 83114701360, Serial Number T2AG14036/112879HL2; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700034/150126HL1; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700033/150126HL1; UDI/DI N/A, System ID Not Available, Serial Number T27G15005/126820HL0; UDI/DI N/A, System ID 600002NM01, Serial Number T27G15004/126534HL7; UDI/DI N/A, System ID 083026806832815, Serial Number T2AG14035/148BH7; UDI/DI N/A, System ID Not Available, Serial Number T2AG14037/112809HL9; UDI/DI N/A, System ID 0835260017, Serial Number T2AG14039/115651HL2; UDI/DI N/A, System ID 5512MI0001, Serial Number T27G15011/130994HL7; UDI/DI N/A, System ID NT5002, Serial Number T27G16021/136626HL9; UDI/DI N/A, System ID NT5003, Serial Number T27G16023/ ; UDI/DI N/A, System ID Not Available, Serial Number T27G16022/137922HL1; UDI/DI N/A, System ID 85150299222, Serial Number T27G1600026/140419HL3; UDI/DI N/A, System ID Not Available, Serial Number T27G15014; UDI/DI N/A, System ID Not Available, Serial Number T27G15015; UDI/DI N/A, System ID Not Available, Serial Number T27G1600027; UDI/DI N/A, System ID Not Available, Serial Number T27G1600028; UDI/DI N/A, System ID Not Available, Serial Number T27G1600029; UDI/DI N/A, System ID Not Available, Serial Number T27G1700037. 3) H2402AC: UDI/DI 840682140904, System ID PK1335NM04, Serial Number NT28G1800003; UDI/DI 840682140904, System ID PK1480NM01, Serial Number NT28G1800004; UDI/DI 840682140904, System ID Not Available, Serial Number NT28G1800002; UDI/DI N/A, System ID Not Available, Serial Number T28G1800005/164844HL3; UDI/DI N/A, System ID Not Available, Serial Number T28G1800006/165131HL4; UDI/DI N/A, System ID Not Available, Serial Number T28G15001; UDI/DI N/A, System ID Not Available, Serial Number T28G15002; UDI/DI N/A, System ID Not Available, Serial Number T28G16003; UDI/DI N/A, System ID Not Available, Serial Number T28G16004; UDI/DI N/A, System ID Not Available, Serial Number T28G16007; UDI/DI N/A, System ID Not Available, Serial Number T28G1600008; UDI/DI N/A, System ID Not Available, Serial Number T28G15002N1; UDI/DI N/A, System ID Not Available, Serial Number T28G1600010; UDI/DI N/A, System ID Not Available, Serial Number T28G1600011; UDI/DI N/A, System ID Not Available, Serial Number T28G1700013; UDI/DI N/A, System ID Not Available, Serial Number T28G1700014; UDI/DI N/A, System ID Not Available, Serial Number T28G1700015; UDI/DI N/A, System ID Not Available, Serial Number T28G1700016; UDI/DI N/A, System ID Not Available, Serial Number T28G1700017; UDI/DI N/A, System ID Not Available, Serial Number T28G1700018; UDI/DI N/A, System ID Not Available, Serial Number T28G1700019; UDI/DI N/A, System ID Not Available, Serial Number T28G1700020; UDI/DI N/A, System ID Not Available, Serial Number T28G1700021; UDI/DI N/A, System ID Not Available, Serial Number T28G1700022; UDI/DI N/A, System ID PK1031NM04, Serial Number T28G1800003/160874HL4; UDI/DI N/A, System ID SA2385NM01, Serial Number T28G1800007/166055HL4; UDI/DI N/A, System ID SA1013MN02, Serial Number T28G1800023/159111HL4; UDI/DI N/A, System ID Not Available, Serial Number T28G1800002/159885HL3; UDI/DI N/A, System ID Not Available, Serial Number T28G1800008/166378HL0; UDI/DI N/A, System ID Not Available, Serial Number T28G16005/135524HL7; UDI/DI N/A, System ID 416494D670A, Serial Number T28G16006/0. 4) H3100AH: UDI/DI 840682121194, System ID Not Available, Serial Number PROV27138; UDI/DI 840682121194, System ID 604875D670A, Serial Number PROV27140; UDI/DI 840682121194, System ID 00137NUC06, Serial Number PROV27144; UDI/DI 840682121194, System ID 562826D670NM, Serial Number PROV27146; UDI/DI 840682121194, System ID Not Available, Serial Number PROV27148; UDI/DI 840682121194, System ID 815599D670, Serial Number PROV27149; UDI/DI 840682121194, System ID 250635D670, Serial Number PROV27152; UDI/DI 840682121194, System ID 614257D670CT, Serial Number PROV27155; UDI/DI 840682121194, System ID 720847NM3, Serial Number PROV27157; UDI/DI 840682121194, System ID 509363NM, Serial Number PROW27162; UDI/DI 840682121194, System ID FI1052MN03, Serial Number PROW27165; UDI/DI 840682121194, System ID RU0004NM01, Serial Number PROW27168; UDI/DI 840682121194, System ID 720847NM2, Serial Number PROW27169; UDI/DI 840682121194, System ID 083026862453817, Serial Number PROW27170; UDI/DI 840682121194, System ID 082426210029, Serial Number PROW27172; UDI/DI 840682121194, System ID 720847NM1, Serial Number PROW27174; UDI/DI 840682121194, System ID 082426300001, Serial Number PROW27177; UDI/DI 840682121194, System ID 082426160059, Serial Number PROW27180; UDI/DI 840682121194, System ID 082426110016, Serial Number PROW27181; UDI/DI 840682121194, System ID 082426080028, Serial Number PROW27182; UDI/DI 840682121194, System ID 082426110015, Serial Number PROW27183; UDI/DI 840682121194, System ID 082426080029, Serial Number PROW27184; UDI/DI 840682121194, System ID 305575NMD670, Serial Number PROW27185; UDI/DI 840682121194, System ID 082426040074, Serial Number PROW27186; UDI/DI 840682121194, System ID 082426130050, Serial Number PROW27188; UDI/DI 840682121194, System ID 082426070045, Serial Number PROW27189; UDI/DI 840682121194, System ID 0853260166, Serial Number PROW27191; UDI/DI 840682121194, System ID 0853260167, Serial Number PROW27194; UDI/DI 840682121194, System ID 082426090048, Serial Number PROW27197; UDI/DI 840682121194, System ID 082426310031, Serial Number PROW27198; UDI/DI 840682121194, System ID 082426150041, Serial Number PROW27199; UDI/DI 840682121194, System ID 0828260035, Serial Number PROW27200; UDI/DI 840682121194, System ID 082426070048, Serial Number PROW27201; UDI/DI 840682121194, System ID 082426090050, Serial Number PROW27202; UDI/DI 840682121194, System ID 083045209826317, Serial Number PROW27203; UDI/DI 840682121194, System ID 0828260034, Serial Number PROW27206; UDI/DI 840682121194, System ID 082426210034, Serial Number PROX27209; UDI/DI 840682121194, System ID 082426190034, Serial Number PROX27210; UDI/DI 840682121194, System ID 082426160060, Serial Number PROX27211; UDI/DI 840682121194, System ID 082426140035, Serial Number PROX27212; UDI/DI 840682121194, System ID 082426030036, Serial Number PROX27213; UDI/DI 840682121194, System ID 082426070047, Serial Number PROX27214; UDI/DI 840682121194, System ID 082426110001, Serial Number PROX27215; UDI/DI 840682121194, System ID 082426100071, Serial Number PROX27216; UDI/DI 840682121194, System ID 082426100076, Serial Number PROX27217; UDI/DI 840682121194, System ID 082426210032, Serial Number PROX27218; UDI/DI 840682121194, System ID 082426150042, Serial Number PROX27219; UDI/DI 840682121194, System ID 082426230031, Serial Number PROX27220; UDI/DI 840682121194, System ID 082426110017, Serial Number PROX27221; UDI/DI 840682121194, System ID 082426280002, Serial Number PROX27222; UDI/DI 840682121194, System ID 082426250008, Serial Number PROX27224; UDI/DI 840682121194, System ID 082426190036, Serial Number PROX27226; UDI/DI 840682121194, System ID 082426090047, Serial Number PROX27227; UDI/DI 840682121194, System ID 082426030039, Serial Number PROX27228; UDI/DI 840682121194, System ID 082426020012, Serial Number PROX27229; UDI/DI 840682121194, System ID 082426230032, Serial Number PROX27230; UDI/DI 840682121194, System ID 082426140036, Serial Number PROX27231; UDI/DI 840682121194, System ID 082426200015, Serial Number PROX27232; UDI/DI 840682121194, System ID 082426120042, Serial Number PROX27233; UDI/DI N/A, System ID 562401D670NM, Serial Number PROV27156; UDI/DI N/A, System ID 510D670, Serial Number 27119; UDI/DI N/A, System ID 720SAND670, Serial Number 27008; UDI/DI N/A, System ID 860545D670, Serial Number 27129; UDI/DI N/A, System ID 727398D670, Serial Number 27021; UDI/DI N/A, System ID 352265D670, Serial Number 27110; UDI/DI N/A, System ID 217732D670, Serial Number 27100; UDI/DI N/A, System ID 630527NM670, Serial Number 27096; UDI/DI N/A, System ID 1000004258, Serial Number 27133; UDI/DI N/A, System ID 217223DISNM, Serial Number 27127; UDI/DI N/A, System ID 301496D670P, Serial Number 27073; UDI/DI N/A, System ID 240314D670NM, Serial Number 27092; UDI/DI N/A, System ID 207373NM670, Serial Number 27117; UDI/DI N/A, System ID 612467DSC670, Serial Number 27094; UDI/DI N/A, System ID 612467DSC670, Serial Number 27105; UDI/DI N/A, System ID NM538029, Serial Number 27102; UDI/DI N/A, System ID 573815D670B, Serial Number 27032; UDI/DI N/A, System ID 573756D670, Serial Number 27055; UDI/DI N/A, System ID 636344NM, Serial Number PROW27158; UDI/DI N/A, System ID 636916D670, Serial Number 27002; UDI/DI N/A, System ID 314996D670, Serial Number 27046; UDI/DI N/A, System ID 314996D670, Serial Number 27062; UDI/DI N/A, System ID AM13ORK48, Serial Number 27065; UDI/DI N/A, System ID 314BARNNM2, Serial Number 27071; UDI/DI N/A, System ID Not Available, Serial Number 27030; UDI/DI N/A, System ID 718854NMD670, Serial Number 27007; UDI/DI N/A, System ID Not Available, Serial Number 27093; UDI/DI N/A, System ID 513CCHB670, Serial Number 27049; UDI/DI N/A, System ID 405720D670, Serial Number 27088; UDI/DI N/A, System ID 918286DIS1, Serial Number 27017; UDI/DI N/A, System ID Not Available, Serial Number 27118; UDI/DI N/A, System ID 412623D670NM1, Serial Number 27106; UDI/DI N/A, System ID 605322D670, Serial Number 27025; UDI/DI N/A, System ID 214820NM670, Serial Number 27040; UDI/DI N/A, System ID 214857NM670A, Serial Number 27044; UDI/DI N/A, System ID 214857NM670B, Serial Number 27083; UDI/DI N/A, System ID Not Available, Serial Number 27045; UDI/DI N/A, System ID UW1NM670, Serial Number 27050; UDI/DI N/A, System ID UW2NM670, Serial Number 27057; UDI/DI N/A, System ID Not Available, Serial Number 27012; UDI/DI N/A, System ID NM1172AR, Serial Number PROX27225; UDI/DI N/A, System ID NM8730AR, Serial Number PROX27223; UDI/DI N/A, System ID 83138055929, Serial Number 27060; UDI/DI N/A, System ID 83149220086, Serial Number 27120; UDI/DI N/A, System ID AH4001NU02, Serial Number 27098; UDI/DI N/A, System ID 030355NU06, Serial Number 27064; UDI/DI N/A, System ID 030388NU08, Serial Number 27020; UDI/DI N/A, System ID 210001NU03, Serial Number 27047; UDI/DI N/A, System ID 080004NU16, Serial Number 27036; UDI/DI N/A, System ID 050045NU01, Serial Number 27048; UDI/DI N/A, System ID 060055NU11, Serial Number 27089; UDI/DI N/A, System ID 220826NU05, Serial Number 27132; UDI/DI N/A, System ID 110034NU06, Serial Number 27031; UDI/DI N/A, System ID 160070NU03, Serial Number 27041; UDI/DI N/A, System ID 030078NU20, Serial Number 27109; UDI/DI N/A, System ID 030028NU03, Serial Number 27091; UDI/DI N/A, System ID 110025NU01, Serial Number PROV27154; UDI/DI N/A, System ID NMPROV27147, Serial Number PROV27147; UDI/DI N/A, System ID NMPROX27208, Serial Number PROX27208; UDI/DI N/A, System ID NMPROW27190, Serial Number PROW27190; UDI/DI N/A, System ID BG4693NM01, Serial Number 27079; UDI/DI N/A, System ID 780492D670A, Serial Number 27081; UDI/DI N/A, System ID 780477D670A, Serial Number 27115; UDI/DI N/A, System ID 204726D671, Serial Number 27082; UDI/DI N/A, System ID 506544D670, Serial Number 27131; UDI/DI N/A, System ID 519663D670A, Serial Number 27051; UDI/DI N/A, System ID 519464BWD670, Serial Number 27124; UDI/DI N/A, System ID NM5641CL, Serial Number 27122; UDI/DI N/A, System ID NMPROW27205, Serial Number PROW27205; UDI/DI N/... |
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.