Z-1112-2026 Class II Ongoing

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

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