Recall archive / FDA device enforcement
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission — FDA record Z-0896-2025
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 Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; 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
- 430 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0896-2025
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) H3100JZ: UDI/DI N/A, System ID UAB640, Serial Number 26139/25146; UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152; UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195; UDI/DI N/A, System ID 602UACC640, Serial Number 26191/25189; UDI/DI N/A, System ID 520VA640, Serial Number 26329/640V25328; UDI/DI N/A, System ID 530756OPT1, Serial Number ONMW26439/640W25433; UDI/DI N/A, System ID 626359D640, Serial Number 26109/25111; UDI/DI N/A, System ID 858824NM640, Serial Number 26221/25222; UDI/DI N/A, System ID 909558NM640, Serial Number 26297/640V25296; UDI/DI N/A, System ID 949364D640, Serial Number ONMW26437/640W25432; UDI/DI N/A, System ID 510437O640, Serial Number 26199/25203; UDI/DI N/A, System ID 714456OPT1, Serial Number ONMX26520/640X25513; UDI/DI N/A, System ID 916973OPT1, Serial Number ONMW26426/640W25422; UDI/DI N/A, System ID 619543NM640, Serial Number 26281/25276; UDI/DI N/A, System ID 415300OPTIMA, Serial Number ONMX26481/640X25475; UDI/DI N/A, System ID 415353D640, Serial Number 26149/25115; UDI/DI N/A, System ID 415221NM640 , Serial Number ONMY26475/640Y25556; UDI/DI N/A, System ID 408559O640, Serial Number ONMX26529/640X25522; UDI/DI N/A, System ID 650742OPTIMA, Serial Number ONMX26518/640X25509; UDI/DI N/A, System ID 209476OPT1, Serial Number 26338/640V25337; UDI/DI N/A, System ID 310222NM640, Serial Number ONMW26418/640W25413; UDI/DI N/A, System ID 707554OPT1, Serial Number 26140/25145; UDI/DI N/A, System ID 303695NM1, Serial Number ONMW26436/640W25431; UDI/DI N/A, System ID 303498NMOPTIMA, Serial Number ONMX26505/640X25500; UDI/DI N/A, System ID 970298NM2, Serial Number ONMX26539/640X25535; UDI/DI N/A, System ID 970298NM1, Serial Number ONMX26528/640X25521; UDI/DI N/A, System ID 303689O640, Serial Number ONMX26538/640X25533; UDI/DI N/A, System ID 303PAHO640B, Serial Number ONMW26415/640W25414; UDI/DI N/A, System ID 303PAHO640, Serial Number 26318/640V25317; UDI/DI N/A, System ID 203576NM640, Serial Number 26336/640V25335; UDI/DI N/A, System ID 860358O640, Serial Number ONMX26519/640X25511; UDI/DI N/A, System ID 203276NM640, Serial Number 26304/640V25301; UDI/DI N/A, System ID 302430NUC640, Serial Number ONMX26530/640X25523; UDI/DI N/A, System ID 302629NM640, Serial Number 26339/640V25339; UDI/DI N/A, System ID Not Available, Serial Number ONMV26378/640V25377; UDI/DI N/A, System ID 407296O640, Serial Number 26174/25171; UDI/DI N/A, System ID 407296NM, Serial Number 26320/640V25319; UDI/DI N/A, System ID 727823D640, Serial Number ONMW26385/640V25382; UDI/DI N/A, System ID Not Available, Serial Number 26268/25261; UDI/DI N/A, System ID 706278640, Serial Number 26168/25170; UDI/DI N/A, System ID Not Available, Serial Number 26196/25197; UDI/DI N/A, System ID 706291NMCT, Serial Number 26167/25166; UDI/DI N/A, System ID 808QMCNM640, Serial Number 26231/25236; UDI/DI N/A, System ID 515699NM1, Serial Number ONMX26512/640X25499; UDI/DI N/A, System ID Not Available, Serial Number 26101/25097; UDI/DI N/A, System ID Not Available, Serial Number 26122/25129; UDI/DI N/A, System ID 847480NM640, Serial Number 26155/25151; UDI/DI N/A, System ID 847234NM640, Serial Number ONMW26408/640W25426; UDI/DI N/A, System ID 847234NM6402, Serial Number ONMW26424/640W25420; UDI/DI N/A, System ID 847990XEL2, Serial Number 26333/640V25332; UDI/DI N/A, System ID 309454NM, Serial Number ONMW26409/640W25407; UDI/DI N/A, System ID 1000004014, Serial Number ONMW26458/640W25453; UDI/DI N/A, System ID 630933NM6402, Serial Number ONMX26503/640X25508; UDI/DI N/A, System ID 630933NM640, Serial Number ONMW26472/640W25467; UDI/DI N/A, System ID 812450NM640, Serial Number 26207/25211; UDI/DI N/A, System ID 812842NM640, Serial Number 26259/25247; UDI/DI N/A, System ID 812238D640, Serial Number ONMW26425/640W25421; UDI/DI N/A, System ID 316962NM640, Serial Number ONMX26513/640X25498; UDI/DI N/A, System ID 859233NM1, Serial Number 26300/640V25299; UDI/DI N/A, System ID 859233NM2, Serial Number 26306/640V25305; UDI/DI N/A, System ID 859233NM3, Serial Number 26319/640V25318; UDI/DI N/A, System ID 502287D640, Serial Number 26217/25220; UDI/DI N/A, System ID 270825NM1, Serial Number ONMV26362/640V25360; UDI/DI N/A, System ID 270575NM640, Serial Number 26099/25105; UDI/DI N/A, System ID 504712D640, Serial Number 26256/25255; UDI/DI N/A, System ID 504712D640, Serial Number 26257/25256; UDI/DI N/A, System ID 318675OPT640, Serial Number 26107/25093; UDI/DI N/A, System ID 508486NM, Serial Number ONMX26489/640X25484; UDI/DI N/A, System ID 617485D640, Serial Number ONMX26491/640X25482; UDI/DI N/A, System ID 443777NM, Serial Number ONMX26511/640X25506; UDI/DI N/A, System ID 410605O640, Serial Number ONMW26428/640W25424; UDI/DI N/A, System ID 240637NMOPT640, Serial Number ONMX26542/640X25538; UDI/DI N/A, System ID 207795NM, Serial Number ONMW26444/640W25440; UDI/DI N/A, System ID 906225NMCT, Serial Number ONMX26510/640X25494; UDI/DI N/A, System ID 952993DSC640, Serial Number ONMX26500/640X25496; UDI/DI N/A, System ID 573814NM, Serial Number ONMW26382/640V25379; UDI/DI N/A, System ID Not Available, Serial Number 26349/640V25344; UDI/DI N/A, System ID 417269OPT640, Serial Number ONMW26413/640W25411; UDI/DI N/A, System ID 314BARN640, Serial Number 26181/25181; UDI/DI N/A, System ID 406237NMOPT, Serial Number ONMX26514/640X25501; UDI/DI N/A, System ID 828298O640, Serial Number 26201/25202; UDI/DI N/A, System ID MINTOPTIMA, Serial Number ONMX26496/640X25489; UDI/DI N/A, System ID CLTVA640, Serial Number 26219/25221; UDI/DI N/A, System ID KERNVA640, Serial Number 26222/25223; UDI/DI N/A, System ID 919784O640, Serial Number 26334/640V25333; UDI/DI N/A, System ID RMCOPTIMA, Serial Number ONMX26507/640X25497; UDI/DI N/A, System ID RMC640, Serial Number ONMW26471/640W25465; UDI/DI N/A, System ID 701239NM640B, Serial Number ONMX26515/640X25529; UDI/DI N/A, System ID 701239NM640, Serial Number 26187/25184; UDI/DI N/A, System ID SHI94701NM640, Serial Number 26346/640V25348; UDI/DI N/A, System ID 402473OPT640, Serial Number ONMX26534/640X25528; UDI/DI N/A, System ID 402481OPT640, Serial Number ONMW26400/640W25398; UDI/DI N/A, System ID 402451D640, Serial Number ONMV26368/640V25366; UDI/DI N/A, System ID Not Available, Serial Number 26292/25291; UDI/DI N/A, System ID 973322NM640, Serial Number ONMW26474/640W25464; UDI/DI N/A, System ID 732775OPT640, Serial Number ONMW26460/640W25452; UDI/DI N/A, System ID 732937OPT640, Serial Number 26280/25279; UDI/DI N/A, System ID 908685OPT6402, Serial Number ONMW26410/640W25408; UDI/DI N/A, System ID 908685D640, Serial Number 26131/25138; UDI/DI N/A, System ID 505983NUCL, Serial Number 26345/640V25343; UDI/DI N/A, System ID Not Available, Serial Number 26309/640V25308; UDI/DI N/A, System ID Not Available, Serial Number 26315/640V25314; UDI/DI N/A, System ID Not Available, Serial Number 26330/640V25329; UDI/DI N/A, System ID Not Available, Serial Number 26312/640V25307; UDI/DI N/A, System ID 518262O640, Serial Number 26270/25268; UDI/DI N/A, System ID 718963OPTIMA640, Serial Number ONMV26376/640V25374; UDI/DI N/A, System ID 716845OPT640, Serial Number 26112/25110; UDI/DI N/A, System ID 716862NM, Serial Number 26269/25267; UDI/DI N/A, System ID 716862NM, Serial Number 26314/640V25313; UDI/DI N/A, System ID Not Available, Serial Number 26332/640V25331; UDI/DI N/A, System ID 518926O640, Serial Number 26341; UDI/DI N/A, System ID 607763OPT640, Serial Number ONMW26461/640W25455; UDI/DI N/A, System ID 330543D640, Serial Number ONMX26490/640X25483; UDI/DI N/A, System ID 740593OPT640, Serial Number ONMX26544/640X25540; UDI/DI N/A, System ID 330363D640RM3, Serial Number ONMW26454/640W25448; UDI/DI N/A, System ID 330363D640RM2, Serial Number ONMW26417/640W25388; UDI/DI N/A, System ID 330363D640RM1, Serial Number ONMW26397/640W25395; UDI/DI N/A, System ID 440285D640, Serial Number ONMX26526/640X25519; UDI/DI N/A, System ID 614MCMN640, Serial Number ONMX26531/640X25524; UDI/DI N/A, System ID 614234NM640, Serial Number ONMW26399/640W25397; UDI/DI N/A, System ID 614234NM640, Serial Number ONMW26389/640W25386; UDI/DI N/A, System ID 937208O640, Serial Number 26251/25254; UDI/DI N/A, System ID 513870NM640, Serial Number ONMX26517/640X25510; UDI/DI N/A, System ID 567208OPTI, Serial Number ONMW26468/640W25462; UDI/DI N/A, System ID 614GCNM640, Serial Number ONMX26527/640X25520; UDI/DI N/A, System ID 614GCNM6402, Serial Number ONMX26524/640X25518; UDI/DI N/A, System ID 614HILL640, Serial Number ONMW26464/640W25459; UDI/DI N/A, System ID Not Available, Serial Number ONMV26375/640V25373; UDI/DI N/A, System ID 419228NM, Serial Number ONMV26367/640V25365; UDI/DI N/A, System ID 740374OPT640, Serial Number ONMW26349/640W25460; UDI/DI N/A, System ID 937523D640, Serial Number 26213/25217; UDI/DI N/A, System ID 419TOLN1, Serial Number 26114/25080; UDI/DI N/A, System ID 614STAN640, Serial Number ONMX26499/640X25493; UDI/DI N/A, System ID 614COOP640, Serial Number ONMW26466/640W25343; UDI/DI N/A, System ID 330263D640, Serial Number 26302/640V25302; UDI/DI N/A, System ID 405271NM640, Serial Number 26095/25190; UDI/DI N/A, System ID 918744NM1, Serial Number 26210/25212; UDI/DI N/A, System ID 918744NM2, Serial Number 26238/25233; UDI/DI N/A, System ID 918744NM3, Serial Number 26271/25273; UDI/DI N/A, System ID 503PRCNM, Serial Number ONMX26493/640X25486; UDI/DI N/A, System ID 541732NM, Serial Number ONMW26447/640W25436; UDI/DI N/A, System ID 503413NM1, Serial Number 26209/25214; UDI/DI N/A, System ID Not Available, Serial Number 26116/25019; UDI/DI N/A, System ID AM1405Y756, Serial Number 26220; UDI/DI N/A, System ID 814877NM640, Serial Number ONMW26470/640W25466; UDI/DI N/A, System ID 570501NM640, Serial Number ONMW26393/640W25389; UDI/DI N/A, System ID 717567NMCT640, Serial Number 26130/25136; UDI/DI N/A, System ID 412822D640, Serial Number ONMW26422/640W25418; UDI/DI N/A, System ID 412748D640, Serial Number 26153/25153; UDI/DI N/A, System ID Not Available, Serial Number ONMW26433/640W25428; UDI/DI N/A, System ID 86512OPTIMA, Serial Number 26205/25207; UDI/DI N/A, System ID 843347O640, Serial Number 26247/25248; UDI/DI N/A, System ID 864560DISC1, Serial Number 26170/25168; UDI/DI N/A, System ID 86450PTMA, Serial Number 26212/25215; UDI/DI N/A, System ID 605347NM640, Serial Number ONMX26546 ; UDI/DI N/A, System ID Not Available, Serial Number 26317/640V25316; UDI/DI N/A, System ID Not Available, Serial Number 26161/25163; UDI/DI N/A, System ID 423431NM1, Serial Number 26156/25142; UDI/DI N/A, System ID Not Available, Serial Number 26298/640V25297; UDI/DI N/A, System ID 901516SO640, Serial Number 26103/25100; UDI/DI N/A, System ID 901516UO640, Serial Number 26299/640V25298; UDI/DI N/A, System ID 615893NM2, Serial Number 26180/25188; UDI/DI N/A, System ID 615222NM1, Serial Number ONMW26398/640W25396; UDI/DI N/A, System ID 806212NM640, Serial Number 26305/640V25304; UDI/DI N/A, System ID 817960NM640, Serial Number 26176/25172; UDI/DI N/A, System ID 817568OP640A, Serial Number 26291/25287; UDI/DI N/A, System ID 817568OP640B, Serial Number 26308/640V25312; UDI/DI N/A, System ID 361SSHNMCT640, Serial Number ONMV26359/640V25357; UDI/DI N/A, System ID 972566NM640, Serial Number 26279/22578; UDI/DI N/A, System ID 682885NM640, Serial Number 26214/25216; UDI/DI N/A, System ID 817877OP640, Serial Number 26347/640V25346; UDI/DI N/A, System ID 713873NMH, Serial Number ONMV26370/640V25367; UDI/DI N/A, System ID 713794NM640, Serial Number ONMW26405/640W25403; UDI/DI N/A, System ID 806775NMCT2, Serial Number 26157/25156; UDI/DI N/A, System ID 806775NMCT2, Serial Number 26185/25186; UDI/DI N/A, System ID 432685NMCT1, Serial Number 26144/25141; UDI/DI N/A, System ID 817639NM640, Serial Number 26134/25139; UDI/DI N/A, System ID MHPEARNM640, Serial Number 26265/25258; UDI/DI N/A, System ID 469814NM640, Serial Number 26193/25194; UDI/DI N/A, System ID Not Available, Serial Number ONMX26516/640X25512; UDI/DI N/A, System ID 210617640OP1, Serial Number 26129/25132; UDI/DI N/A, System ID 210617640OP2, Serial Number 26184/25185; UDI... |
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.