Recall archive / FDA device enforcement
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission — FDA record Z-0897-2025
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 Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; 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
- 877 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0897-2025
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) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133; UDI/DI N/A, System ID 256543INF1, Serial Number 17182; UDI/DI N/A, System ID 205408INF2, Serial Number 18157; UDI/DI N/A, System ID 256429INF1, Serial Number 17557; UDI/DI N/A, System ID 256327NUC, Serial Number 17900; UDI/DI N/A, System ID 334418INF, Serial Number 17266; UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970; UDI/DI N/A, System ID 205750INF, Serial Number 16802; UDI/DI N/A, System ID 501776INF, Serial Number 17294; UDI/DI N/A, System ID 479463INF2, Serial Number 16900; UDI/DI N/A, System ID 501202INF, Serial Number 16564; UDI/DI N/A, System ID 479967INF, Serial Number 16817; UDI/DI N/A, System ID 479549INF, Serial Number 18319; UDI/DI N/A, System ID 479751INF, Serial Number 16800; UDI/DI N/A, System ID 928214INF, Serial Number 17075; UDI/DI N/A, System ID 520868INF, Serial Number 18289; UDI/DI N/A, System ID 602588INF, Serial Number 17054; UDI/DI N/A, System ID 623406INF1, Serial Number 17064; UDI/DI N/A, System ID 480512INF2, Serial Number 18250; UDI/DI N/A, System ID 623478NM2, Serial Number 16223; UDI/DI N/A, System ID 602406INF, Serial Number 17739; UDI/DI N/A, System ID 602406OPINF, Serial Number 17746; UDI/DI N/A, System ID 480324INF, Serial Number 17150; UDI/DI N/A, System ID 480323INFRM2, Serial Number 17584; UDI/DI N/A, System ID 480882INF2, Serial Number 17998; UDI/DI N/A, System ID 441236INFINIA, Serial Number 16912; UDI/DI N/A, System ID 925779IN, Serial Number 17618; UDI/DI N/A, System ID 805489INF1, Serial Number 17043; UDI/DI N/A, System ID 6502IN2, Serial Number 17962; UDI/DI N/A, System ID 760452INF1, Serial Number 18399; UDI/DI N/A, System ID 415925INF, Serial Number 16863; UDI/DI N/A, System ID 661949NUC1, Serial Number 17730; UDI/DI N/A, System ID 805737INF1, Serial Number 17772; UDI/DI N/A, System ID 323268INF1, Serial Number 17456; UDI/DI N/A, System ID 209385IN, Serial Number 16963; UDI/DI N/A, System ID 951696INF1, Serial Number 16541; UDI/DI N/A, System ID 951672INF1, Serial Number 18114; UDI/DI N/A, System ID RADNETMR547, Serial Number 17183; UDI/DI N/A, System ID 760778INF1, Serial Number 17292; UDI/DI N/A, System ID 661PMCNUC1, Serial Number 17726; UDI/DI N/A, System ID 415222IN1, Serial Number 16437; UDI/DI N/A, System ID 805543INF1, Serial Number 17752; UDI/DI N/A, System ID 310832INF1, Serial Number 17617; UDI/DI N/A, System ID 818907INF1, Serial Number 16648; UDI/DI N/A, System ID 818884INF1, Serial Number 17657; UDI/DI N/A, System ID 303839INF, Serial Number 16790; UDI/DI N/A, System ID 303450INF, Serial Number 18194; UDI/DI N/A, System ID 203797INF, Serial Number 17221; UDI/DI N/A, System ID 203852INF, Serial Number 17320; UDI/DI N/A, System ID RADNETNM1750, Serial Number 17393; UDI/DI N/A, System ID 302733INF, Serial Number 17997; UDI/DI N/A, System ID 610459INF, Serial Number 18560; UDI/DI N/A, System ID RADNETNM1750, Serial Number 16474; UDI/DI N/A, System ID 302629INF, Serial Number 17897; UDI/DI N/A, System ID 302428INF, Serial Number 16559; UDI/DI N/A, System ID 305682INF1, Serial Number 16692; UDI/DI N/A, System ID 352596INF1, Serial Number 16804; UDI/DI N/A, System ID 786308INF1, Serial Number 17368; UDI/DI N/A, System ID 786308INF2, Serial Number 17448; UDI/DI N/A, System ID 904321INF1, Serial Number 17838; UDI/DI N/A, System ID 352333INF, Serial Number 16412; UDI/DI N/A, System ID 954265INF1, Serial Number 18144; UDI/DI N/A, System ID 727863INF1, Serial Number 17418; UDI/DI N/A, System ID 352344INF, Serial Number 17359; UDI/DI N/A, System ID 904821NM1, Serial Number 16209; UDI/DI N/A, System ID 904821NM2, Serial Number 16228; UDI/DI N/A, System ID 904202INF1, Serial Number 17394; UDI/DI N/A, System ID 904821INF3, Serial Number 17684; UDI/DI N/A, System ID 904627INF2, Serial Number 17715; UDI/DI N/A, System ID 904627INF1, Serial Number 17761; UDI/DI N/A, System ID 561744INF, Serial Number 16734; UDI/DI N/A, System ID 561744INF2, Serial Number 18293; UDI/DI N/A, System ID 863679INF1, Serial Number 17117; UDI/DI N/A, System ID 727581INF, Serial Number 17787; UDI/DI N/A, System ID 954735INF2, Serial Number 16920; UDI/DI N/A, System ID 954978INF1, Serial Number 18030; UDI/DI N/A, System ID 305325INF, Serial Number 16792; UDI/DI N/A, System ID 239NCHINF1, Serial Number 17968; UDI/DI N/A, System ID 904276INF1, Serial Number 18228; UDI/DI N/A, System ID 941235INF, Serial Number 16305; UDI/DI N/A, System ID 941766INF2, Serial Number 16326; UDI/DI N/A, System ID 941637INF, Serial Number 16045; UDI/DI N/A, System ID 904819INF1, Serial Number 16660; UDI/DI N/A, System ID 727521INF, Serial Number 17564; UDI/DI N/A, System ID CFRHINF, Serial Number 17992; UDI/DI N/A, System ID 813870INF, Serial Number 16783; UDI/DI N/A, System ID 727942INF, Serial Number 17144; UDI/DI N/A, System ID 727843INF1, Serial Number 18231; UDI/DI N/A, System ID 941VRMCINF, Serial Number 17864; UDI/DI N/A, System ID 386362INF1, Serial Number 18336; UDI/DI N/A, System ID 561650INF1, Serial Number 16964; UDI/DI N/A, System ID 229SUMINF, Serial Number 18254; UDI/DI N/A, System ID 404712INF, Serial Number 16262; UDI/DI N/A, System ID 404265INF, Serial Number 16969; UDI/DI N/A, System ID 404686INF, Serial Number 17186; UDI/DI N/A, System ID 706733INF, Serial Number 17402; UDI/DI N/A, System ID 770382INM, Serial Number 16656; UDI/DI N/A, System ID 706278INF, Serial Number 17947; UDI/DI N/A, System ID 770535INF1, Serial Number 17246; UDI/DI N/A, System ID 770219INF, Serial Number 17558; UDI/DI N/A, System ID 478633INFINIA, Serial Number 16768; UDI/DI N/A, System ID 478454INF, Serial Number 18059; UDI/DI N/A, System ID 912486EGNC, Serial Number 16767; UDI/DI N/A, System ID 229259INF, Serial Number 16662; UDI/DI N/A, System ID 229333ICINF1, Serial Number 18146; UDI/DI N/A, System ID 229333ICINF2, Serial Number 18163; UDI/DI N/A, System ID 319272INF, Serial Number 18119; UDI/DI N/A, System ID 630312INF, Serial Number 17119; UDI/DI N/A, System ID 773665INF2, Serial Number 16415; UDI/DI N/A, System ID 773665INF1, Serial Number 16418; UDI/DI N/A, System ID 773884INF, Serial Number 17305; UDI/DI N/A, System ID 773947INF, Serial Number 17554; UDI/DI N/A, System ID 773995INF, Serial Number 17866; UDI/DI N/A, System ID 815756INF, Serial Number 17218; UDI/DI N/A, System ID 630275INF, Serial Number 16542; UDI/DI N/A, System ID 630275INF2, Serial Number 18260; UDI/DI N/A, System ID 217347INFINIA, Serial Number 16770; UDI/DI N/A, System ID 217347INF2, Serial Number 17851; UDI/DI N/A, System ID 630545INF, Serial Number 16553; UDI/DI N/A, System ID 618942INF, Serial Number 17826; UDI/DI N/A, System ID 847480INF, Serial Number 17443; UDI/DI N/A, System ID 630856INF, Serial Number 16470; UDI/DI N/A, System ID 815432INF, Serial Number 17806; UDI/DI N/A, System ID 847990INF1, Serial Number 18066; UDI/DI N/A, System ID 618993INF, Serial Number 17239; UDI/DI N/A, System ID 708684INF1, Serial Number 17769; UDI/DI N/A, System ID 708660INF, Serial Number 17969; UDI/DI N/A, System ID 618234INF1, Serial Number 17516; UDI/DI N/A, System ID 618395INF, Serial Number 17676; UDI/DI N/A, System ID 708747INFACQ, Serial Number 16319; UDI/DI N/A, System ID 618544INF, Serial Number 17201; UDI/DI N/A, System ID 630786INF, Serial Number 17815; UDI/DI N/A, System ID 217544NUC1, Serial Number 16937; UDI/DI N/A, System ID 815432INFINIA, Serial Number 17403; UDI/DI N/A, System ID 309655INF1, Serial Number 16991; UDI/DI N/A, System ID 309344SMNUC, Serial Number 16923; UDI/DI N/A, System ID 815395INF, Serial Number 18164; UDI/DI N/A, System ID 618256INF1, Serial Number 17790; UDI/DI N/A, System ID 765552INF, Serial Number 17748; UDI/DI N/A, System ID 317415INF, Serial Number 18145; UDI/DI N/A, System ID 812842INF1, Serial Number 16628; UDI/DI N/A, System ID 812522INF, Serial Number 16411; UDI/DI N/A, System ID 620225WPI, Serial Number 17073; UDI/DI N/A, System ID 913588INF1, Serial Number 17991; UDI/DI N/A, System ID 913541INF1, Serial Number 17235; UDI/DI N/A, System ID 913345INF1, Serial Number 17240; UDI/DI N/A, System ID 316858GI, Serial Number 17216; UDI/DI N/A, System ID 316268VCFI2, Serial Number 17367; UDI/DI N/A, System ID 502350INF, Serial Number 17698; UDI/DI N/A, System ID 502868INF1, Serial Number 16303; UDI/DI N/A, System ID 859313INF, Serial Number 17468; UDI/DI N/A, System ID 859268INF1, Serial Number 17872; UDI/DI N/A, System ID 606878INF2, Serial Number 17941; UDI/DI N/A, System ID 502259INF, Serial Number 16477; UDI/DI N/A, System ID 502893INF, Serial Number 16621; UDI/DI N/A, System ID 859498INF1, Serial Number 18160; UDI/DI N/A, System ID 225381INF, Serial Number 16528; UDI/DI N/A, System ID 504826INF, Serial Number 18446; UDI/DI N/A, System ID 225647INF, Serial Number 17129; UDI/DI N/A, System ID 985230INF, Serial Number 17524; UDI/DI N/A, System ID 225NOINF, Serial Number 18088; UDI/DI N/A, System ID 504873INF2, Serial Number 16475; UDI/DI N/A, System ID 504873INF2, Serial Number 17397; UDI/DI N/A, System ID 337981INF, Serial Number 16634; UDI/DI N/A, System ID 337436INF, Serial Number 16772; UDI/DI N/A, System ID 985785INF, Serial Number 17006; UDI/DI N/A, System ID 225INFINIA, Serial Number 16683; UDI/DI N/A, System ID 225INFINIA, Serial Number 16814; UDI/DI N/A, System ID 504454INF, Serial Number 17862; UDI/DI N/A, System ID 318388INF1, Serial Number 17311; UDI/DI N/A, System ID 318327INF1, Serial Number 17315; UDI/DI N/A, System ID 318330INF1, Serial Number 17364; UDI/DI N/A, System ID 337943INF, Serial Number 17142; UDI/DI N/A, System ID 504537INF, Serial Number 17878; UDI/DI N/A, System ID 318681INFINIA2, Serial Number 17012; UDI/DI N/A, System ID 318798INFINIA, Serial Number 18165; UDI/DI N/A, System ID 985646INF, Serial Number 16877; UDI/DI N/A, System ID 985649INF1, Serial Number 17883; UDI/DI N/A, System ID 985649INF2, Serial Number 17893; UDI/DI N/A, System ID 225658INF, Serial Number 16984; UDI/DI N/A, System ID 508457INF, Serial Number 18316; UDI/DI N/A, System ID 978521INF, Serial Number 17366; UDI/DI N/A, System ID 781979INF1, Serial Number 16221; UDI/DI N/A, System ID 617243INFINIA, Serial Number 17735; UDI/DI N/A, System ID 774442INF, Serial Number 18015; UDI/DI N/A, System ID RADNETNM1753, Serial Number 17789; UDI/DI N/A, System ID 443481BINF, Serial Number 17971; UDI/DI N/A, System ID 301877INF, Serial Number 16491; UDI/DI N/A, System ID 240566INF, Serial Number 17902; UDI/DI N/A, System ID RADNETNM1754, Serial Number 18063; UDI/DI N/A, System ID 410337INF2, Serial Number 16715; UDI/DI N/A, System ID 410337INF3, Serial Number 16816; UDI/DI N/A, System ID 207795INFINIA, Serial Number 17141; UDI/DI N/A, System ID 313343INF2, Serial Number 17111; UDI/DI N/A, System ID 313343INF4, Serial Number 17552; UDI/DI N/A, System ID 313343INF3, Serial Number 17555; UDI/DI N/A, System ID 248471INF, Serial Number 17970; UDI/DI N/A, System ID 616267INFINIA, Serial Number 17263; UDI/DI N/A, System ID 616267INFINIA, Serial Number 17993; UDI/DI N/A, System ID 906293INF, Serial Number 16408; UDI/DI N/A, System ID 248898INF, Serial Number 16497; UDI/DI N/A, System ID 248898INF2, Serial Number 17454; UDI/DI N/A, System ID 248849INF1, Serial Number 17177; UDI/DI N/A, System ID 248849INF2, Serial Number 17253; UDI/DI N/A, System ID 734671INF, Serial Number 16672; UDI/DI N/A, System ID 734467INF, Serial Number 16667; UDI/DI N/A, System ID 218847INF, Serial Number 18298; UDI/DI N/A, System ID 816348INF1, Serial Number 17553; UDI/DI N/A, System ID 816380CASSINF, Serial Number 17753; UDI/DI N/A, System ID 816836CIIN, Serial Number 16988; UDI/DI N/A, System ID 816404INF1, Serial Number 17303; UDI/DI N/A, System ID 573686INF1, Serial Number 16285; UDI/DI N/A, System ID 573686INF2, Serial Number 18173; UDI/DI N/A, System ID CSNMINFINIA, Serial Number 18299; UDI/DI N/A, System ID 662256INFINIA, Serial Number 17451; UDI/DI N/A, System ID 228436INF, Seri... |
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.