GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
FDA recall Z-1112-2026 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
FDA recall Z-1112-2026: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
The FDA logged enforcement record Z-1112-2026: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission — reason: There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-24. Affected lots/codes: OMNI Legend 16: UDI (01)00195278454218(21)OM3D31087(11)240400, Manufacturing Lot/Serial Number OM3D31087; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31071(11)240200, Manufacturing Lot/Serial Number OM3D31071; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31100(11)240700, Manufacturing Lot/Serial Number OM3D31100; OMNI Legend 16: UDI (01)00195278454218(21)OM3E31115(11)250100, Manufacturing Lot/Serial Number OM3E31115; OMNI Legend 16: UDI (01)00195278592309(21)OH3D35001(11)240600, Manufacturing Lot/Serial Number OH3D35001; OMNI Legend 16: UDI (01)00195278592309(21)OH3E35003(11)250100, Manufacturing Lot/Serial Number OH3E35003; Omni Legend 21: UDI (01)00195278454218(21)OM4E44014(11)250400, Manufacturing Lot/Serial Number OM4E44014; Omni Legend 21: UDI (01)00195278454218(21)OM4E44012(11)250200, Manufacturing Lot/Serial Number OM4E44012; Omni Legend 21: UDI (01)00195278592309(21)OH4E43004(11)250400, Manufacturing Lot/Serial Number OH4E43004; Omni Legend 21: UDI (01)00195278592309(21)OH4E43001(11)250100, Manufacturing Lot/Serial Number OH4E43001; Omni Legend 21: UDI (01)00195278592309(21)OH4E43002(11)250100, Manufacturing Lot/Serial Number OH4E43002; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61101(11)250400, Manufacturing Lot/Serial Number OM6E61101; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61084(11)240900, Manufacturing Lot/Serial Number OM6D61084; OMNI Legend 32: UDI (01)00195278454218(21)OM6C61031(11)230700, Manufacturing Lot/Serial Number OM6C61031; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61097(11)250200, Manufacturing Lot/Serial Number OM6E61097; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61072(11)240600, Manufacturing Lot/Serial Number OM6D61072; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250623(21)NL1EG2500002BH, Manufacturing Lot/Serial Number NL1EG2500002BH/ CBDDG2500041HM/ C1PMT2500115HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240900(21)NL1EG2400002BH, Manufacturing Lot/Serial Number NL1EG2400002BH/ CBDDG2400112HM/ C1PMT2400271HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240600(21)NL1EG2400001BH, Manufacturing Lot/Serial Number NL1EG2400001BH /CBDDG2400079HM/C1PMT2400151HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250100(21)NL1EG2400003BH, Manufacturing Lot/Serial Number NL1EG2400003BH/ NL1EG2400003BH /CBDDG2400144HM/ C1PMT2400123HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250400(21)NL1EG2500001BH, Manufacturing Lot/Serial Number NL1EG2500001BH/ CBDDG2500026HM/ C1PMT2500074HM; Omni Legend PET Gantry 16cm Haifa LM: UDI (01)00195278592309(21)OH3D35002(11)241000, Manufacturing Lot/Serial Number OH3D35002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32001(11)230600, Manufacturing Lot/Serial Number OW3C32001; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32002(11)230700, Manufacturing Lot/Serial Number OW3C32002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32003(11)230900, Manufacturing Lot/Serial Number OW3C32003; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32006(11)231000, Manufacturing Lot/Serial Number OW3C32006; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32010(11)231100, Manufacturing Lot/Serial Number OW3C32010; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32018(11)240500, Manufacturing Lot/Serial Number OW3D32018; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32021(11)241000, Manufacturing Lot/Serial Number OW3D32021; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32013(11)240100, Manufacturing Lot/Serial Number OW3D32013; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32007(11)231000, Manufacturing Lot/Serial Number OW3C32007; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32020(11)240700, Manufacturing Lot/Serial Number OW3D32020; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32019(11)240500, Manufacturing Lot/Serial Number OW3D32019; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32014(11)240100, Manufacturing Lot/Serial Number OW3D32014; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32015(11)240100, Manufacturing Lot/Serial Number OW3D32015; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32004(11)230900, Manufacturing Lot/Serial Number OW3C32004; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32011(11)231200, Manufacturing Lot/Serial Number OW3C32011; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32005(11)231000, Manufacturing Lot/Serial Number OW3C32005; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32008(11)231000, Manufacturing Lot/Serial Number OW3C32008; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32016(11)240300, Manufacturing Lot/Serial Number OW3D32016; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32012(11)240100, Manufacturing Lot/Serial Number OW3D32012; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32009(11)231000, Manufacturing Lot/Serial Number OW3C32009; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3E32022(11)250400, Manufacturing Lot/Serial Number OW3E32022; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241000(21)NL1FG2400003BH, Manufacturing Lot/Serial Number NL1FG2400003BH /CBDDG2400119HM/ C1PMT2400296HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241000(21)NL1FG2400004BH, Manufacturing Lot/Serial Number NL1FG2400004BH /CBDDG2400121HM/ C1PMT2400305HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241200(21)NL1FG2500001BH, Manufacturing Lot/Serial Number NL1FG2500001BH/ CBDDG2400143HM /C1PMT2300279HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250200(21)NL1FG2500002BH, Manufacturing Lot/Serial Number NL1FG2500002BH/ CBDDG2500009HM/ C1PMT2500018HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250506(21)NL1FG2500003BH, Manufacturing Lot/Serial Number NL1FG2500003BH/ CBDDG2500030HM/ C1PMT2500083HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)240500(21)NL1FG2400001BH, Manufacturing Lot/Serial Number NL1FG2400001BH/ CBDDG2400063HM/ C1PMT2400126HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)240900(21)NL1FG2400002BH, Manufacturing Lot/Serial Number NL1FG2400002BH/ CBDDG2400109HM/ C1PMT2400245HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250509(21)NL1FG2500004BH, Manufacturing Lot/Serial Number NL1FG2500004BH/ CBDDG2500032HM/ C1PMT2500086HM; Omni Legend PET Gantry 21cm - Global Haifa LM: UDI (01)00195278592309(21)OH4E43005(11)250609, Manufacturing Lot/Serial Number OH4E43005; Omni Legend PET Gantry 21cm - Global Haifa LM: UDI (01)00195278592309(21)OH4E43003(11)250300, Manufacturing Lot/Serial Number OH4E43003; Omni Legend PET Gantry 21cm - Mobile: UDI (01)00195278454218(21)OW4D47001(11)241100, Manufacturing Lot/Serial Number OW4D47001; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44003(11)240800, Manufacturing Lot/Serial Number OM4D44003; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44009(11)241100, Manufacturing Lot/Serial Number OM4D44009; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44002(11)240500, Manufacturing Lot/Serial Number OM4D44002; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44006(11)241000, Manufacturing Lot/Serial Number OM4D44006; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44017(11)250528, Manufacturing Lot/Serial Number OM4E44017; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44008(11)241100, Manufacturing Lot/Serial Number OM4D44008; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44005(11)241000, Manufacturing Lot/Serial Number OM4D44005; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44015(11)250512, Manufacturing Lot/Serial Number OM4E44015; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44013(11)250300, Manufacturing Lot/Serial Number OM4E44013; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44010(11)250300, Manufacturing Lot/Serial Number OM4E44010; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44007(11)241100, Manufacturing Lot/Serial Number OM4D44007; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44016(11)250525, Manufacturing Lot/Serial Number OM4E44016; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44001(11)240300, Manufacturing Lot/Serial Number OM4D44001; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44011(11)250200, Manufacturing Lot/Serial Number OM4E44011; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44004(11)240900, Manufacturing Lot/Serial Number OM4D44004; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241000(21)NL1DG2400006BH, Manufacturing Lot/Serial Number NL1DG2400006BH /CBDDG2400115HM /C1PMT2400277HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250619(21)NL1DG2500007BH, Manufacturing Lot/Serial Number NL1DG2500007BH/ CBDDG2500042HM/C1PMT2500116HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400003BH, Manufacturing Lot/Serial Number NL1DG2400003BH/ CBDDG2400091HM/ C1PMT2400185HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250521(21)NL1DG2500005BH, Manufacturing Lot/Serial Number NL1DG2500005BH/ CBDDG2500037HM/ C1PMT2500093HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250702(21)NL1DG2500008BH, Manufacturing Lot/Serial Number NL1DG2500008BH/ CBDDG2500043HM/ C1PMT2500121HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250515(21)NL1DG2500004BH, Manufacturing Lot/Serial Number NL1DG2500004BH/ CBDDG2500034HM/ C1PMT2500089HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400002BH, Manufacturing Lot/Serial Number NL1DG2400002BH/ CBDDG2400083HM/ C1PMT2400172HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400004BH, Manufacturing Lot/Serial Number NL1DG2400004BH/ CBDDG2400096HM /C1PMT2400197HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250611(21)NL1DG2500006BH, Manufacturing Lot/Serial Number NL1DG2500006BH/ CBDDG2500040HM/ C1PMT2500111HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)231100(21)NL1DG2400001BH, Manufacturing Lot/Serial Number NL1DG2400001BH; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250200(21)NL1DG2500002BH, Manufacturing Lot/Serial Number NL1DG2500002BH/ CBDDG2500015HM/ C1PMT2500053HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241100(21)NL1DG2400007BH, Manufacturing Lot/Serial Number NL1DG2400007BH /CBDDG2400131HM/ C1PMT2400328HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240800(21)NL1DG2400005BH, Manufacturing Lot/Serial Number NL1DG2400005BH/ CBDDG2400108HM /C1PMT2400226; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241200(21)NL1DG2400008BH, Manufacturing Lot/Serial Number NL1DG2400008BH/ CBDDG2400142HM/ C1PMT2400342HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250400(21)NL1DG2500003BH, Manufacturing Lot/Serial Number NL1DG2500003BH /CBDDG2500025HM/ C1PMT2500071HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250100(21)NL1DG2500001BH, Manufacturing Lot/Serial Number NL1DG2500001BH/ CBDDG2500007HM/ C1PMT2500012HM; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66004(11)241100, Manufacturing Lot/Serial Number OH6D66004; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66001(11)240200, Manufacturing Lot/Serial Number OH6D66001; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66002(11)240500, Manufacturing Lot/Serial Number OH6D66002; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66003(11)241000, Manufacturing Lot/Serial Number OH6D66003; Omni Legend PET Gantry 32cm Mobile: UDI (01)00195278454218(21)OW6D62001(11)240200, Manufacturing Lot/Serial Number OW6D62001; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31063(11)240100, Manufacturing Lot/Serial Number OM3D31063; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31072(11)240200, Manufacturing Lot/Serial Number OM3D31072; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31064(11)240100, Manufacturing Lot/Serial Number OM3D31064; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31050(11)231100, Manufacturing Lot/Serial Number OM3C31050; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31044(11)231100, Manufacturing Lot/Serial Number OM3C31044; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31058(11)240100, Manufacturing Lot/Serial Number OM3D31058; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31009(11)230200, Manufacturing Lot/Serial Number OM3C31009; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31065(11)240100, Manufacturing Lot/Serial Number OM3D31065; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31040(11)231000, Manufacturing Lot/Serial Number OM3C31040; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31025(11)230600, Manufacturing Lot/Serial Number OM3C31025; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31059(11)240100, Manufacturing Lot/Serial Number OM3D31059; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31069(11)240200, Manufacturing Lot/Serial Number OM3D31069; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31034(11)230800, Manufacturing Lot/Serial Number OM3C31034; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31015(11)230300, Manufacturing Lot/Serial Number OM3C31015; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31021(11)230500, Manufacturing Lot/Serial Number OM3C31021; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31102(11)240700, Manufacturing Lot/Serial Number OM3D31102; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31103(11)240700, Manufacturing Lot/Serial Number OM3D31103; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31061(11)240100, Manufacturing Lot/Serial Number OM3D31061; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31091(11)240500, Manufacturing Lot/Serial Number OM3D31091; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31079(11)240400, Manufacturing Lot/Serial Number OM3D31079; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31006(11)230100, Manufacturing Lot/Serial Number OM3C31006; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31074(11)240200, Manufacturing Lot/Serial Number OM3D31074; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31056(11)240100, Manufacturing Lot/Serial Number OM3D31056; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31042(11)231000, Manufacturing Lot/Serial Number OM3C31042; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31097(11)240600, Manufacturing Lot/Serial Number OM3D31097; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31007(11)230100, Manufacturing Lot/Serial Number OM3C31007; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31053(11)231100, Manufacturing Lot/Serial Number OM3C31053; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31038(11)231000, Manufacturing Lot/Serial Number OM3C31038; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31081(11)240400, Manufacturing Lot/Serial Number OM3D31081; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31062(11)240100, Manufacturing Lot/Serial Number OM3D31062; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31090(11)240500, Manufacturing Lot/Serial Number OM3D31090; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31043(11)231100, Manufacturing Lot/Serial Number OM3C31043; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31075(11)240200, Manufacturing Lot/Serial Number OM3D31075; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31078(11)240400, Manufacturing Lot/Serial Number OM3D31078; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31084(11)240400, Manufacturing Lot/Serial Number OM3D31084; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31028(11)230700, Manufacturing Lot/Serial Number OM3C31028; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31037(11)231000, Manufacturing Lot/Serial Number OM3C31037; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31114(11)241200, Manufacturing Lot/Serial Number OM3D31114; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31104(11)240700, Manufacturing Lot/Serial Number OM3D31104; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31066(11)240100, Manufacturing Lot/Serial Number OM3D31066; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31014(11)230300, Manufacturing Lot/Serial Number OM3C31014; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31027(11)230700, Manufacturing Lot/Serial Number OM3C31027; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31004(11)221200, Manufacturing Lot/Serial Number OM3B31004; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31086(11)240400, Manufacturing Lot/Serial Number OM3D31086; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31024(11)230600, Manufacturing Lot/Serial Number OM3C31024; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31080(11)240400, Manufacturing Lot/Serial Number OM3D31080; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31096(11)240600, Manufacturing Lot/Serial Number OM3D31096; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31047(11)231100, Manufacturing Lot/Serial Number OM3C31047; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31035(11)230800, Manufacturing Lot/Serial Number OM3C31035; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31085(11)240400, Manufacturing Lot/Serial Number OM3D31085; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31011(11)230200, Manufacturing Lot/Serial Number OM3C31011; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31008(11)230200, Manufacturing Lot/Serial Number OM3C31008; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31049(11)231100, Manufacturing Lot/Serial Number OM3C31049; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31073(11)240200, Manufacturing Lot/Serial Number OM3D31073; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31093(11)240500, Manufacturing Lot/Serial Number OM3D31093; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31022(11)230500, Manufacturing Lot/Serial Number OM3C31022; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31101(11)240700, Manufacturing Lot/Serial Number OM3D31101; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31033(11)230800, Manufacturing Lot/Serial Number OM3C31033; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31077(11)240400, Manufacturing Lot/Serial Number OM3D31077; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31105(11)240700, Manufacturing Lot/Serial Number OM3D31105; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31010(11)230200, Manufacturing Lot/Serial Number OM3C31010; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31020(11)230500, Manufacturing Lot/Serial Number OM3C31020; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31005(11)221200, Manufacturing Lot/Serial Number OM3B31005; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31013(11)230300, Manufacturing Lot/Serial Number OM3C31013; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31076(11)240400, Manufacturing Lot/Serial Number OM3D31076; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31088(11)240500, Manufacturing Lot/Serial Number OM3D31088; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31051(11)231100, Manufacturing Lot/Serial Number OM3C31051; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31095(11)240500, Manufacturing Lot/Serial Number OM3D31095; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31055(11)240100, Manufacturing Lot/Serial Number OM3D31055; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31023(11)230500, Manufacturing Lot/Serial Number OM3C31023; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31001(11)220600, Manufacturing Lot/Serial Number OM3B31001; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31029(11)230700, Manufacturing Lot/Serial Number OM3C31029; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31019(11)230500, Manufacturing Lot/Serial Number OM3C31019; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31041(11)231000, Manufacturing Lot/Serial Number OM3C31041; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31016(11)230300, Manufacturing Lot/Serial Number OM3C31016; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31032(11)230800, Manufacturing Lot/Serial Number OM3C31032; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31094(11)240500, Manufacturing Lot/Serial Number OM3D31094; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31089(11)240500, Manufacturing Lot/Serial Number OM3D31089; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31057(11)240100, Manufacturing Lot/Serial Number OM3D31057; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31107(11)240800, Manufacturing Lot/Serial Number OM3D31107; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31036(11)230900, Manufacturing Lot/Serial Number OM3C31036; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31030(11)230700, Manufacturing Lot/Serial Number OM3C31030; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31012(11)230200, Manufacturing Lot/Serial Number OM3C31012; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31083(11)240400, Manufacturing Lot/Serial Number OM3D31083; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31031(11)230800, Manufacturing Lot/Serial Number OM3C31031; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31112(11)241100, Manufacturing Lot/Serial Number OM3D31112; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31110(11)240800, Manufacturing Lot/Serial Number OM3D31110; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31116(11)250100, Manufacturing Lot/Serial Number OM3E31116; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31092(11)240500, Manufacturing Lot/Serial Number OM3D31092; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31113(11)241100, Manufacturing Lot/Serial Number OM3D31113; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31052(11)231100, Manufacturing Lot/Serial Number OM3C31052; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31117(11)250400, Manufacturing Lot/Serial Number OM3E31117; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31003(11)221100, Manufacturing Lot/Serial Number OM3B31003; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31070(11)240200, Manufacturing Lot/Serial Number OM3D31070; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31067(11)240200, Manufacturing Lot/Serial Number OM3D31067; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31046(11)231100, Manufacturing Lot/Serial Number OM3C31046; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31048(11)231100, Manufacturing Lot/Serial Number OM3C31048; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31039(11)231000, Manufacturing Lot/Serial Number OM3C31039; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31099(11)240700, Manufacturing Lot/Serial Number OM3D31099; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31098(11)240600, Manufacturing Lot/Serial Number OM3D31098; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31111(11)240900, Manufacturing Lot/Serial Number OM3D31111; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31118(11)250500, Manufacturing Lot/Serial Number OM3E31118; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31109(11)240900, Manufacturing Lot/Serial Number OM3D31109; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31108(11)240800, Manufacturing Lot/Serial Number OM3D31108; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31068(11)240200, Manufacturing Lot/Serial Number OM3D31068; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31106(11)240800, Manufacturing Lot/Serial Number OM3D31106; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31054(11)231200, Manufacturing Lot/Serial Number OM3C31054; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31017(11)230500, Manufacturing Lot/Serial Number OM3C31017; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31018(11)230500, Manufacturing Lot/Serial Number OM3C31018; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31026(11)230600, Manufacturing Lot/Serial Number OM3C31026; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31060(11)240100, Manufacturing Lot/Serial Number OM3D31060; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31082(11)240400, Manufacturing Lot/Serial Number OM3D31082; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250708(21)OMW152500014PT, Manufacturing Lot/Serial Number OMW152500014PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241004(21)OMW152400004PT, Manufacturing Lot/Serial Number OMW152400004PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241213(21)OMW152400008PT, Manufacturing Lot/Serial Number OMW152400008PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500010PT, Manufacturing Lot/Serial Number OMW152500010PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241106(21)OMW152400006PT, Manufacturing Lot/Serial Number OMW152400006PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250410(21)OMW152500012PT, Manufacturing Lot/Serial Number OMW152500012PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250423(21)OMW152500013PT, Manufacturing Lot/Serial Number OMW152500013PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500009PT, Manufacturing Lot/Serial Number OMW152500009PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)240926(21)OMW152400003PT, Manufacturing Lot/Serial Number OMW152400003PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250310(21)OMW152500011PT, Manufacturing Lot/Serial Number OMW152500011PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241028(21)OMW152400005PT, Manufacturing Lot/Serial Number OMW152400005PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250710(21)OMW152500015PT, Manufacturing Lot/Serial Number OMW152500015PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241114(21)OMW152400007PT, Manufacturing Lot/Serial Number OMW152400007PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)240919(21)OMW152400002PT, Manufacturing Lot/Serial Number OMW152400002PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500001PT, Manufacturing Lot/Serial Number OMW152500001PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250623(21)OMC152500008PT, Manufacturing Lot/Serial Number OMC152500008PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250520(21)OMC152500006PT, Manufacturing Lot/Serial Number OMC152500006PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250120(21)OMC152500001PT, Manufacturing Lot/Serial Number OMC152500001PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250325(21)OMC152500005PT, Manufacturing Lot/Serial Number OMC152500005PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250128(21)OMC152500002PT, Manufacturing Lot/Serial Number OMC152500002PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241209(21)OMC152400007PT, Manufacturing Lot/Serial Number OMC152400007PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241120(21)OMC152400004PT, Manufacturing Lot/Serial Number OMC152400004PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241211(21)OMC152400008PT, Manufacturing Lot/Serial Number OMC152400008PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241014(21)OMC152400001PT, Manufacturing Lot/Serial Number OMC152400001PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241018(21)OMC152400002PT, Manufacturing Lot/Serial Number OMC152400002PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250228(21)OMC152500003PT, Manufacturing Lot/Serial Number OMC152500003PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250321(21)OMC152500004PT, Manufacturing Lot/Serial Number OMC152500004PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241023(21)OMC152400003PT, Manufacturing Lot/Serial Number OMC152400003PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241125(21)OMC152400005PT, Manufacturing Lot/Serial Number OMC152400005PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241204(21)OMC152400006PT, Manufacturing Lot/Serial Number OMC152400006PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250612(21)OMC152500007PT, Manufacturing Lot/Serial Number OMC152500007PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250408(21)OMD152500004PT, Manufacturing Lot/Serial Number OMD152500004PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250304(21)OMD152500003PT, Manufacturing Lot/Serial Number OMD152500003PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250218(21)OMD152500002PT, Manufacturing Lot/Serial Number OMD152500002PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250603(21)OMD152500006PT, Manufacturing Lot/Serial Number OMD152500006PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250410(21)OMD152500005PT, Manufacturing Lot/Serial Number OMD152500005PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250213(21)OMD152500001PT, Manufacturing Lot/Serial Number OMD152500001PT; Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)241217(21)OMM152400001PT, Manufacturing Lot/Serial Number OMM152400001PT; Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)250206(21)OMM152500001PT, Manufacturing Lot/Serial Number OMM152500001PT; Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)250410(21)OMM152500002PT, Manufacturing Lot/Serial Number OMM152500002PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250617(21)OMW212500007PT, Manufacturing Lot/Serial Number OMW212500007PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250220(21)OMW212500001PT, Manufacturing Lot/Serial Number OMW212500001PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250604(21)OMW212500006PT, Manufacturing Lot/Serial Number OMW212500006PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250519(21)OMW212500004PT, Manufacturing Lot/Serial Number OMW212500004PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250501(21)OMW212500003PT, Manufacturing Lot/Serial Number OMW212500003PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250313(21)OMW212500002PT, Manufacturing Lot/Serial Number OMW212500002PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250529(21)OMW212500005PT, Manufacturing Lot/Serial Number OMW212500005PT; Omni PET Gantry 21cm Mobile - WSO: UDI (01)00195278901439(11)250710(21)OMM212500001PT, Manufacturing Lot/Serial Number OMM212500001PT; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61041(11)230900, Manufacturing Lot/Serial Number OM6C61041; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61020(11)230500, Manufacturing Lot/Serial Number OM6C61020; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61010(11)221100, Manufacturing Lot/Serial Number OM6B61010; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61070(11)240600, Manufacturing Lot/Serial Number OM6D61070; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61050(11)231100, Manufacturing Lot/Serial Number OM6C61050; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61053(11)231100, Manufacturing Lot/Serial Number OM6C61053; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61083(11)240800, Manufacturing Lot/Serial Number OM6D61083; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61021(11)230500, Manufacturing Lot/Serial Number OM6C61021; OMNI PET. A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-1112-2026 as Class II
The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
OMNI Legend 16: UDI (01)00195278454218(21)OM3D31087(11)240400, Manufacturing Lot/Serial Number OM3D31087; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31071(11)240200, Manufacturing Lot/Serial Number OM3D31071; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31100(11)240700, Manufacturing Lot/Serial Number OM3D31100; OMNI Legend 16: UDI (01)00195278454218(21)OM3E31115(11)250100, Manufacturing Lot/Serial Number OM3E31115; OMNI Legend 16: UDI (01)00195278592309(21)OH3D35001(11)240600, Manufacturing Lot/Serial Number OH3D35001; OMNI Legend 16: UDI (01)00195278592309(21)OH3E35003(11)250100, Manufacturing Lot/Serial Number OH3E35003; Omni Legend 21: UDI (01)00195278454218(21)OM4E44014(11)250400, Manufacturing Lot/Serial Number OM4E44014; Omni Legend 21: UDI (01)00195278454218(21)OM4E44012(11)250200, Manufacturing Lot/Serial Number OM4E44012; Omni Legend 21: UDI (01)00195278592309(21)OH4E43004(11)250400, Manufacturing Lot/Serial Number OH4E43004; Omni Legend 21: UDI (01)00195278592309(21)OH4E43001(11)250100, Manufacturing Lot/Serial Number OH4E43001; Omni Legend 21: UDI (01)00195278592309(21)OH4E43002(11)250100, Manufacturing Lot/Serial Number OH4E43002; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61101(11)250400, Manufacturing Lot/Serial Number OM6E61101; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61084(11)240900, Manufacturing Lot/Serial Number OM6D61084; OMNI Legend 32: UDI (01)00195278454218(21)OM6C61031(11)230700, Manufacturing Lot/Serial Number OM6C61031; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61097(11)250200, Manufacturing Lot/Serial Number OM6E61097; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61072(11)240600, Manufacturing Lot/Serial Number OM6D61072; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250623(21)NL1EG2500002BH, Manufacturing Lot/Serial Number NL1EG2500002BH/ CBDDG2500041HM/ C1PMT2500115HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240900(21)NL1EG2400002BH, Manufacturing Lot/Serial Number NL1EG2400002BH/ CBDDG2400112HM/ C1PMT2400271HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240600(21)NL1EG2400001BH, Manufacturing Lot/Serial Number NL1EG2400001BH /CBDDG2400079HM/C1PMT2400151HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250100(21)NL1EG2400003BH, Manufacturing Lot/Serial Number NL1EG2400003BH/ NL1EG2400003BH /CBDDG2400144HM/ C1PMT2400123HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250400(21)NL1EG2500001BH, Manufacturing Lot/Serial Number NL1EG2500001BH/ CBDDG2500026HM/ C1PMT2500074HM; Omni Legend PET Gantry 16cm Haifa LM: UDI (01)00195278592309(21)OH3D35002(11)241000, Manufacturing Lot/Serial Number OH3D35002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32001(11)230600, Manufacturing Lot/Serial Number OW3C32001; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32002(11)230700, Manufacturing Lot/Serial Number OW3C32002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32003(11)230900, Manufacturing Lot/Serial Number OW3C32003; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32006(11)231000, Manufacturing Lot/Serial Number OW3C32006; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32010(11)231100, Manufacturing Lot/Serial Number OW3C32010; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32018(11)240500, Manufacturing Lot/Serial Number OW3D32018; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32021(11)241000, Manufacturing Lot/Serial Number OW3D32021; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32013(11)240100, Manufacturing Lot/Serial Number OW3D32013; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32007(11)231000, Manufacturing Lot/Serial Number OW3C32007; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32020(11)240700, Manufacturing Lot/Serial Number OW3D32020; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32019(11)240500, Manufacturing Lot/Serial Number OW3D32019; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32014(11)240100, Manufacturing Lot/Serial Number OW3D32014; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32015(11)240100, Manufacturing Lot/Serial Number OW3D32015; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32004(11)230900, Manufacturing Lot/Serial Number OW3C32004; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32011(11)231200, Manufacturing Lot/Serial Number OW3C32011; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32005(11)231000, Manufacturing Lot/Serial Number OW3C32005; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32008(11)231000, Manufacturing Lot/Serial Number OW3C32008; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32016(11)240300, Manufacturing Lot/Serial Number OW3D32016; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32012(11)240100, Manufacturing Lot/Serial Number OW3D32012; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32009(11)231000, Manufacturing Lot/Serial Number OW3C32009; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3E32022(11)250400, Manufacturing Lot/Serial Number OW3E32022; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241000(21)NL1FG2400003BH, Manufacturing Lot/Serial Number NL1FG2400003BH /CBDDG2400119HM/ C1PMT2400296HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241000(21)NL1FG2400004BH, Manufacturing Lot/Serial Number NL1FG2400004BH /CBDDG2400121HM/ C1PMT2400305HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241200(21)NL1FG2500001BH, Manufacturing Lot/Serial Number NL1FG2500001BH/ CBDDG2400143HM /C1PMT2300279HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250200(21)NL1FG2500002BH, Manufacturing Lot/Serial Number NL1FG2500002BH/ CBDDG2500009HM/ C1PMT2500018HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250506(21)NL1FG2500003BH, Manufacturing Lot/Serial Number NL1FG2500003BH/ CBDDG2500030HM/ C1PMT2500083HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)240500(21)NL1FG2400001BH, Manufacturing Lot/Serial Number NL1FG2400001BH/ CBDDG2400063HM/ C1PMT2400126HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)240900(21)NL1FG2400002BH, Manufacturing Lot/Serial Number NL1FG2400002BH/ CBDDG2400109HM/ C1PMT2400245HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250509(21)NL1FG2500004BH, Manufacturing Lot/Serial Number NL1FG2500004BH/ CBDDG2500032HM/ C1PMT2500086HM; Omni Legend PET Gantry 21cm - Global Haifa LM: UDI (01)00195278592309(21)OH4E43005(11)250609, Manufacturing Lot/Serial Number OH4E43005; Omni Legend PET Gantry 21cm - Global Haifa LM: UDI (01)00195278592309(21)OH4E43003(11)250300, Manufacturing Lot/Serial Number OH4E43003; Omni Legend PET Gantry 21cm - Mobile: UDI (01)00195278454218(21)OW4D47001(11)241100, Manufacturing Lot/Serial Number OW4D47001; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44003(11)240800, Manufacturing Lot/Serial Number OM4D44003; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44009(11)241100, Manufacturing Lot/Serial Number OM4D44009; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44002(11)240500, Manufacturing Lot/Serial Number OM4D44002; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44006(11)241000, Manufacturing Lot/Serial Number OM4D44006; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44017(11)250528, Manufacturing Lot/Serial Number OM4E44017; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44008(11)241100, Manufacturing Lot/Serial Number OM4D44008; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44005(11)241000, Manufacturing Lot/Serial Number OM4D44005; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44015(11)250512, Manufacturing Lot/Serial Number OM4E44015; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44013(11)250300, Manufacturing Lot/Serial Number OM4E44013; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44010(11)250300, Manufacturing Lot/Serial Number OM4E44010; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44007(11)241100, Manufacturing Lot/Serial Number OM4D44007; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44016(11)250525, Manufacturing Lot/Serial Number OM4E44016; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44001(11)240300, Manufacturing Lot/Serial Number OM4D44001; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44011(11)250200, Manufacturing Lot/Serial Number OM4E44011; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44004(11)240900, Manufacturing Lot/Serial Number OM4D44004; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241000(21)NL1DG2400006BH, Manufacturing Lot/Serial Number NL1DG2400006BH /CBDDG2400115HM /C1PMT2400277HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250619(21)NL1DG2500007BH, Manufacturing Lot/Serial Number NL1DG2500007BH/ CBDDG2500042HM/C1PMT2500116HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400003BH, Manufacturing Lot/Serial Number NL1DG2400003BH/ CBDDG2400091HM/ C1PMT2400185HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250521(21)NL1DG2500005BH, Manufacturing Lot/Serial Number NL1DG2500005BH/ CBDDG2500037HM/ C1PMT2500093HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250702(21)NL1DG2500008BH, Manufacturing Lot/Serial Number NL1DG2500008BH/ CBDDG2500043HM/ C1PMT2500121HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250515(21)NL1DG2500004BH, Manufacturing Lot/Serial Number NL1DG2500004BH/ CBDDG2500034HM/ C1PMT2500089HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400002BH, Manufacturing Lot/Serial Number NL1DG2400002BH/ CBDDG2400083HM/ C1PMT2400172HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400004BH, Manufacturing Lot/Serial Number NL1DG2400004BH/ CBDDG2400096HM /C1PMT2400197HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250611(21)NL1DG2500006BH, Manufacturing Lot/Serial Number NL1DG2500006BH/ CBDDG2500040HM/ C1PMT2500111HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)231100(21)NL1DG2400001BH, Manufacturing Lot/Serial Number NL1DG2400001BH; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250200(21)NL1DG2500002BH, Manufacturing Lot/Serial Number NL1DG2500002BH/ CBDDG2500015HM/ C1PMT2500053HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241100(21)NL1DG2400007BH, Manufacturing Lot/Serial Number NL1DG2400007BH /CBDDG2400131HM/ C1PMT2400328HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240800(21)NL1DG2400005BH, Manufacturing Lot/Serial Number NL1DG2400005BH/ CBDDG2400108HM /C1PMT2400226; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241200(21)NL1DG2400008BH, Manufacturing Lot/Serial Number NL1DG2400008BH/ CBDDG2400142HM/ C1PMT2400342HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250400(21)NL1DG2500003BH, Manufacturing Lot/Serial Number NL1DG2500003BH /CBDDG2500025HM/ C1PMT2500071HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250100(21)NL1DG2500001BH, Manufacturing Lot/Serial Number NL1DG2500001BH/ CBDDG2500007HM/ C1PMT2500012HM; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66004(11)241100, Manufacturing Lot/Serial Number OH6D66004; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66001(11)240200, Manufacturing Lot/Serial Number OH6D66001; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66002(11)240500, Manufacturing Lot/Serial Number OH6D66002; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66003(11)241000, Manufacturing Lot/Serial Number OH6D66003; Omni Legend PET Gantry 32cm Mobile: UDI (01)00195278454218(21)OW6D62001(11)240200, Manufacturing Lot/Serial Number OW6D62001; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31063(11)240100, Manufacturing Lot/Serial Number OM3D31063; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31072(11)240200, Manufacturing Lot/Serial Number OM3D31072; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31064(11)240100, Manufacturing Lot/Serial Number OM3D31064; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31050(11)231100, Manufacturing Lot/Serial Number OM3C31050; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31044(11)231100, Manufacturing Lot/Serial Number OM3C31044; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31058(11)240100, Manufacturing Lot/Serial Number OM3D31058; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31009(11)230200, Manufacturing Lot/Serial Number OM3C31009; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31065(11)240100, Manufacturing Lot/Serial Number OM3D31065; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31040(11)231000, Manufacturing Lot/Serial Number OM3C31040; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31025(11)230600, Manufacturing Lot/Serial Number OM3C31025; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31059(11)240100, Manufacturing Lot/Serial Number OM3D31059; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31069(11)240200, Manufacturing Lot/Serial Number OM3D31069; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31034(11)230800, Manufacturing Lot/Serial Number OM3C31034; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31015(11)230300, Manufacturing Lot/Serial Number OM3C31015; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31021(11)230500, Manufacturing Lot/Serial Number OM3C31021; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31102(11)240700, Manufacturing Lot/Serial Number OM3D31102; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31103(11)240700, Manufacturing Lot/Serial Number OM3D31103; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31061(11)240100, Manufacturing Lot/Serial Number OM3D31061; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31091(11)240500, Manufacturing Lot/Serial Number OM3D31091; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31079(11)240400, Manufacturing Lot/Serial Number OM3D31079; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31006(11)230100, Manufacturing Lot/Serial Number OM3C31006; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31074(11)240200, Manufacturing Lot/Serial Number OM3D31074; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31056(11)240100, Manufacturing Lot/Serial Number OM3D31056; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31042(11)231000, Manufacturing Lot/Serial Number OM3C31042; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31097(11)240600, Manufacturing Lot/Serial Number OM3D31097; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31007(11)230100, Manufacturing Lot/Serial Number OM3C31007; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31053(11)231100, Manufacturing Lot/Serial Number OM3C31053; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31038(11)231000, Manufacturing Lot/Serial Number OM3C31038; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31081(11)240400, Manufacturing Lot/Serial Number OM3D31081; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31062(11)240100, Manufacturing Lot/Serial Number OM3D31062; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31090(11)240500, Manufacturing Lot/Serial Number OM3D31090; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31043(11)231100, Manufacturing Lot/Serial Number OM3C31043; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31075(11)240200, Manufacturing Lot/Serial Number OM3D31075; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31078(11)240400, Manufacturing Lot/Serial Number OM3D31078; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31084(11)240400, Manufacturing Lot/Serial Number OM3D31084; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31028(11)230700, Manufacturing Lot/Serial Number OM3C31028; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31037(11)231000, Manufacturing Lot/Serial Number OM3C31037; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31114(11)241200, Manufacturing Lot/Serial Number OM3D31114; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31104(11)240700, Manufacturing Lot/Serial Number OM3D31104; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31066(11)240100, Manufacturing Lot/Serial Number OM3D31066; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31014(11)230300, Manufacturing Lot/Serial Number OM3C31014; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31027(11)230700, Manufacturing Lot/Serial Number OM3C31027; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31004(11)221200, Manufacturing Lot/Serial Number OM3B31004; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31086(11)240400, Manufacturing Lot/Serial Number OM3D31086; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31024(11)230600, Manufacturing Lot/Serial Number OM3C31024; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31080(11)240400, Manufacturing Lot/Serial Number OM3D31080; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31096(11)240600, Manufacturing Lot/Serial Number OM3D31096; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31047(11)231100, Manufacturing Lot/Serial Number OM3C31047; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31035(11)230800, Manufacturing Lot/Serial Number OM3C31035; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31085(11)240400, Manufacturing Lot/Serial Number OM3D31085; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31011(11)230200, Manufacturing Lot/Serial Number OM3C31011; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31008(11)230200, Manufacturing Lot/Serial Number OM3C31008; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31049(11)231100, Manufacturing Lot/Serial Number OM3C31049; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31073(11)240200, Manufacturing Lot/Serial Number OM3D31073; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31093(11)240500, Manufacturing Lot/Serial Number OM3D31093; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31022(11)230500, Manufacturing Lot/Serial Number OM3C31022; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31101(11)240700, Manufacturing Lot/Serial Number OM3D31101; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31033(11)230800, Manufacturing Lot/Serial Number OM3C31033; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31077(11)240400, Manufacturing Lot/Serial Number OM3D31077; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31105(11)240700, Manufacturing Lot/Serial Number OM3D31105; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31010(11)230200, Manufacturing Lot/Serial Number OM3C31010; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31020(11)230500, Manufacturing Lot/Serial Number OM3C31020; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31005(11)221200, Manufacturing Lot/Serial Number OM3B31005; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31013(11)230300, Manufacturing Lot/Serial Number OM3C31013; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31076(11)240400, Manufacturing Lot/Serial Number OM3D31076; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31088(11)240500, Manufacturing Lot/Serial Number OM3D31088; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31051(11)231100, Manufacturing Lot/Serial Number OM3C31051; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31095(11)240500, Manufacturing Lot/Serial Number OM3D31095; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31055(11)240100, Manufacturing Lot/Serial Number OM3D31055; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31023(11)230500, Manufacturing Lot/Serial Number OM3C31023; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31001(11)220600, Manufacturing Lot/Serial Number OM3B31001; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31029(11)230700, Manufacturing Lot/Serial Number OM3C31029; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31019(11)230500, Manufacturing Lot/Serial Number OM3C31019; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31041(11)231000, Manufacturing Lot/Serial Number OM3C31041; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31016(11)230300, Manufacturing Lot/Serial Number OM3C31016; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31032(11)230800, Manufacturing Lot/Serial Number OM3C31032; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31094(11)240500, Manufacturing Lot/Serial Number OM3D31094; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31089(11)240500, Manufacturing Lot/Serial Number OM3D31089; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31057(11)240100, Manufacturing Lot/Serial Number OM3D31057; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31107(11)240800, Manufacturing Lot/Serial Number OM3D31107; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31036(11)230900, Manufacturing Lot/Serial Number OM3C31036; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31030(11)230700, Manufacturing Lot/Serial Number OM3C31030; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31012(11)230200, Manufacturing Lot/Serial Number OM3C31012; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31083(11)240400, Manufacturing Lot/Serial Number OM3D31083; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31031(11)230800, Manufacturing Lot/Serial Number OM3C31031; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31112(11)241100, Manufacturing Lot/Serial Number OM3D31112; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31110(11)240800, Manufacturing Lot/Serial Number OM3D31110; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31116(11)250100, Manufacturing Lot/Serial Number OM3E31116; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31092(11)240500, Manufacturing Lot/Serial Number OM3D31092; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31113(11)241100, Manufacturing Lot/Serial Number OM3D31113; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31052(11)231100, Manufacturing Lot/Serial Number OM3C31052; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31117(11)250400, Manufacturing Lot/Serial Number OM3E31117; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31003(11)221100, Manufacturing Lot/Serial Number OM3B31003; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31070(11)240200, Manufacturing Lot/Serial Number OM3D31070; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31067(11)240200, Manufacturing Lot/Serial Number OM3D31067; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31046(11)231100, Manufacturing Lot/Serial Number OM3C31046; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31048(11)231100, Manufacturing Lot/Serial Number OM3C31048; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31039(11)231000, Manufacturing Lot/Serial Number OM3C31039; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31099(11)240700, Manufacturing Lot/Serial Number OM3D31099; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31098(11)240600, Manufacturing Lot/Serial Number OM3D31098; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31111(11)240900, Manufacturing Lot/Serial Number OM3D31111; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31118(11)250500, Manufacturing Lot/Serial Number OM3E31118; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31109(11)240900, Manufacturing Lot/Serial Number OM3D31109; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31108(11)240800, Manufacturing Lot/Serial Number OM3D31108; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31068(11)240200, Manufacturing Lot/Serial Number OM3D31068; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31106(11)240800, Manufacturing Lot/Serial Number OM3D31106; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31054(11)231200, Manufacturing Lot/Serial Number OM3C31054; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31017(11)230500, Manufacturing Lot/Serial Number OM3C31017; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31018(11)230500, Manufacturing Lot/Serial Number OM3C31018; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31026(11)230600, Manufacturing Lot/Serial Number OM3C31026; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31060(11)240100, Manufacturing Lot/Serial Number OM3D31060; OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31082(11)240400, Manufacturing Lot/Serial Number OM3D31082; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250708(21)OMW152500014PT, Manufacturing Lot/Serial Number OMW152500014PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241004(21)OMW152400004PT, Manufacturing Lot/Serial Number OMW152400004PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241213(21)OMW152400008PT, Manufacturing Lot/Serial Number OMW152400008PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500010PT, Manufacturing Lot/Serial Number OMW152500010PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241106(21)OMW152400006PT, Manufacturing Lot/Serial Number OMW152400006PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250410(21)OMW152500012PT, Manufacturing Lot/Serial Number OMW152500012PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250423(21)OMW152500013PT, Manufacturing Lot/Serial Number OMW152500013PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500009PT, Manufacturing Lot/Serial Number OMW152500009PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)240926(21)OMW152400003PT, Manufacturing Lot/Serial Number OMW152400003PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250310(21)OMW152500011PT, Manufacturing Lot/Serial Number OMW152500011PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241028(21)OMW152400005PT, Manufacturing Lot/Serial Number OMW152400005PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250710(21)OMW152500015PT, Manufacturing Lot/Serial Number OMW152500015PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241114(21)OMW152400007PT, Manufacturing Lot/Serial Number OMW152400007PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)240919(21)OMW152400002PT, Manufacturing Lot/Serial Number OMW152400002PT; Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500001PT, Manufacturing Lot/Serial Number OMW152500001PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250623(21)OMC152500008PT, Manufacturing Lot/Serial Number OMC152500008PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250520(21)OMC152500006PT, Manufacturing Lot/Serial Number OMC152500006PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250120(21)OMC152500001PT, Manufacturing Lot/Serial Number OMC152500001PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250325(21)OMC152500005PT, Manufacturing Lot/Serial Number OMC152500005PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250128(21)OMC152500002PT, Manufacturing Lot/Serial Number OMC152500002PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241209(21)OMC152400007PT, Manufacturing Lot/Serial Number OMC152400007PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241120(21)OMC152400004PT, Manufacturing Lot/Serial Number OMC152400004PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241211(21)OMC152400008PT, Manufacturing Lot/Serial Number OMC152400008PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241014(21)OMC152400001PT, Manufacturing Lot/Serial Number OMC152400001PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241018(21)OMC152400002PT, Manufacturing Lot/Serial Number OMC152400002PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250228(21)OMC152500003PT, Manufacturing Lot/Serial Number OMC152500003PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250321(21)OMC152500004PT, Manufacturing Lot/Serial Number OMC152500004PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241023(21)OMC152400003PT, Manufacturing Lot/Serial Number OMC152400003PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241125(21)OMC152400005PT, Manufacturing Lot/Serial Number OMC152400005PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241204(21)OMC152400006PT, Manufacturing Lot/Serial Number OMC152400006PT; OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250612(21)OMC152500007PT, Manufacturing Lot/Serial Number OMC152500007PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250408(21)OMD152500004PT, Manufacturing Lot/Serial Number OMD152500004PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250304(21)OMD152500003PT, Manufacturing Lot/Serial Number OMD152500003PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250218(21)OMD152500002PT, Manufacturing Lot/Serial Number OMD152500002PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250603(21)OMD152500006PT, Manufacturing Lot/Serial Number OMD152500006PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250410(21)OMD152500005PT, Manufacturing Lot/Serial Number OMD152500005PT; OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250213(21)OMD152500001PT, Manufacturing Lot/Serial Number OMD152500001PT; Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)241217(21)OMM152400001PT, Manufacturing Lot/Serial Number OMM152400001PT; Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)250206(21)OMM152500001PT, Manufacturing Lot/Serial Number OMM152500001PT; Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)250410(21)OMM152500002PT, Manufacturing Lot/Serial Number OMM152500002PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250617(21)OMW212500007PT, Manufacturing Lot/Serial Number OMW212500007PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250220(21)OMW212500001PT, Manufacturing Lot/Serial Number OMW212500001PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250604(21)OMW212500006PT, Manufacturing Lot/Serial Number OMW212500006PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250519(21)OMW212500004PT, Manufacturing Lot/Serial Number OMW212500004PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250501(21)OMW212500003PT, Manufacturing Lot/Serial Number OMW212500003PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250313(21)OMW212500002PT, Manufacturing Lot/Serial Number OMW212500002PT; Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250529(21)OMW212500005PT, Manufacturing Lot/Serial Number OMW212500005PT; Omni PET Gantry 21cm Mobile - WSO: UDI (01)00195278901439(11)250710(21)OMM212500001PT, Manufacturing Lot/Serial Number OMM212500001PT; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61041(11)230900, Manufacturing Lot/Serial Number OM6C61041; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61020(11)230500, Manufacturing Lot/Serial Number OM6C61020; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61010(11)221100, Manufacturing Lot/Serial Number OM6B61010; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61070(11)240600, Manufacturing Lot/Serial Number OM6D61070; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61050(11)231100, Manufacturing Lot/Serial Number OM6C61050; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61053(11)231100, Manufacturing Lot/Serial Number OM6C61053; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61083(11)240800, Manufacturing Lot/Serial Number OM6D61083; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61021(11)230500, Manufacturing Lot/Serial Number OM6C61021; OMNI PET
Worldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, United Kingdom, and Uzbekistan.