GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Omni Legend
Reason for recall
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).
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- (01)00195278454218(21)OM3D31087(11)240400, Manufacturing Lot/
- Serial #
- OM3D31087; OMNI Legend 16:
- UDI
- (01)00195278454218(21)OM3D31071(11)240200, Manufacturing Lot/
- Serial #
- OM3D31071; OMNI Legend 16:
- UDI
- (01)00195278454218(21)OM3D31100(11)240700, Manufacturing Lot/
- Serial #
- OM3D31100; OMNI Legend 16:
- UDI
- (01)00195278454218(21)OM3E31115(11)250100, Manufacturing Lot/
- Serial #
- OM3E31115; OMNI Legend 16:
- UDI
- (01)00195278592309(21)OH3D35001(11)240600, Manufacturing Lot/
- Serial #
- OH3D35001; OMNI Legend 16:
- UDI
- (01)00195278592309(21)OH3E35003(11)250100, Manufacturing Lot/
- Serial #
- OH3E35003; Omni Legend 21:
- UDI
- (01)00195278454218(21)OM4E44014(11)250400, Manufacturing Lot/
- Serial #
- OM4E44014; Omni Legend 21:
- UDI
- (01)00195278454218(21)OM4E44012(11)250200, Manufacturing Lot/
- Serial #
- OM4E44012; Omni Legend 21:
- UDI
- (01)00195278592309(21)OH4E43004(11)250400, Manufacturing Lot/
- Serial #
- OH4E43004; Omni Legend 21:
- UDI
- (01)00195278592309(21)OH4E43001(11)250100, Manufacturing Lot/
- Serial #
- OH4E43001; Omni Legend 21:
- UDI
- (01)00195278592309(21)OH4E43002(11)250100, Manufacturing Lot/
- Serial #
- OH4E43002; OMNI Legend 32:
- UDI
- (01)00195278454218(21)OM6E61101(11)250400, Manufacturing Lot/
- Serial #
- OM6E61101; OMNI Legend 32:
- UDI
- (01)00195278454218(21)OM6D61084(11)240900, Manufacturing Lot/
- Serial #
- OM6D61084; OMNI Legend 32:
- UDI
- (01)00195278454218(21)OM6C61031(11)230700, Manufacturing Lot/
- Serial #
- OM6C61031; OMNI Legend 32:
- UDI
- (01)00195278454218(21)OM6E61097(11)250200, Manufacturing Lot/
- Serial #
- OM6E61097; OMNI Legend 32:
- UDI
- (01)00195278454218(21)OM6D61072(11)240600, Manufacturing Lot/
- Serial #
- OM6D61072; Omni Legend PET Gantry 16cm - MEA:
- UDI
- (01)00195278792822(11)250623(21)NL1EG2500002BH, Manufacturing Lot/
- Serial #
- NL1EG2500002BH/ CBDDG2500041HM/ C1PMT2500115HM; Omni Legend PET Gantry 16cm - MEA:
- UDI
- (01)00195278792822(11)240900(21)NL1EG2400002BH, Manufacturing Lot/
- Serial #
- NL1EG2400002BH/ CBDDG2400112HM/ C1PMT2400271HM; Omni Legend PET Gantry 16cm - MEA:
- UDI
- (01)00195278792822(11)240600(21)NL1EG2400001BH, Manufacturing Lot/
- Serial #
- NL1EG2400001BH /CBDDG2400079HM/C1PMT2400151HM; Omni Legend PET Gantry 16cm - MEA:
- UDI
- (01)00195278792822(11)250100(21)NL1EG2400003BH, Manufacturing Lot/
- Serial #
- NL1EG2400003BH/ NL1EG2400003BH /CBDDG2400144HM/ C1PMT2400123HM; Omni Legend PET Gantry 16cm - MEA:
- UDI
- (01)00195278792822(11)250400(21)NL1EG2500001BH, Manufacturing Lot/
- Serial #
- NL1EG2500001BH/ CBDDG2500026HM/ C1PMT2500074HM; Omni Legend PET Gantry 16cm Haifa LM:
- UDI
- (01)00195278592309(21)OH3D35002(11)241000, Manufacturing Lot/
- Serial #
- OH3D35002; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32001(11)230600, Manufacturing Lot/
- Serial #
- OW3C32001; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32002(11)230700, Manufacturing Lot/
- Serial #
- OW3C32002; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32003(11)230900, Manufacturing Lot/
- Serial #
- OW3C32003; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32006(11)231000, Manufacturing Lot/
- Serial #
- OW3C32006; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32010(11)231100, Manufacturing Lot/
- Serial #
- OW3C32010; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32018(11)240500, Manufacturing Lot/
- Serial #
- OW3D32018; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32021(11)241000, Manufacturing Lot/
- Serial #
- OW3D32021; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32013(11)240100, Manufacturing Lot/
- Serial #
- OW3D32013; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32007(11)231000, Manufacturing Lot/
- Serial #
- OW3C32007; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32020(11)240700, Manufacturing Lot/
- Serial #
- OW3D32020; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32019(11)240500, Manufacturing Lot/
- Serial #
- OW3D32019; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32014(11)240100, Manufacturing Lot/
- Serial #
- OW3D32014; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32015(11)240100, Manufacturing Lot/
- Serial #
- OW3D32015; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32004(11)230900, Manufacturing Lot/
- Serial #
- OW3C32004; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32011(11)231200, Manufacturing Lot/
- Serial #
- OW3C32011; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32005(11)231000, Manufacturing Lot/
- Serial #
- OW3C32005; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32008(11)231000, Manufacturing Lot/
- Serial #
- OW3C32008; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32016(11)240300, Manufacturing Lot/
- Serial #
- OW3D32016; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3D32012(11)240100, Manufacturing Lot/
- Serial #
- OW3D32012; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3C32009(11)231000, Manufacturing Lot/
- Serial #
- OW3C32009; Omni Legend PET Gantry 16cm Mobile:
- UDI
- (01)00195278454218(21)OW3E32022(11)250400, Manufacturing Lot/
- Serial #
- OW3E32022; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)241000(21)NL1FG2400003BH, Manufacturing Lot/
- Serial #
- NL1FG2400003BH /CBDDG2400119HM/ C1PMT2400296HM; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)241000(21)NL1FG2400004BH, Manufacturing Lot/
- Serial #
- NL1FG2400004BH /CBDDG2400121HM/ C1PMT2400305HM; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)241200(21)NL1FG2500001BH, Manufacturing Lot/
- Serial #
- NL1FG2500001BH/ CBDDG2400143HM /C1PMT2300279HM; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)250200(21)NL1FG2500002BH, Manufacturing Lot/
- Serial #
- NL1FG2500002BH/ CBDDG2500009HM/ C1PMT2500018HM; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)250506(21)NL1FG2500003BH, Manufacturing Lot/
- Serial #
- NL1FG2500003BH/ CBDDG2500030HM/ C1PMT2500083HM; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)240500(21)NL1FG2400001BH, Manufacturing Lot/
- Serial #
- NL1FG2400001BH/ CBDDG2400063HM/ C1PMT2400126HM; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)240900(21)NL1FG2400002BH, Manufacturing Lot/
- Serial #
- NL1FG2400002BH/ CBDDG2400109HM/ C1PMT2400245HM; Omni Legend PET Gantry 21cm - BJ for Global:
- UDI
- (01)00195278792822(11)250509(21)NL1FG2500004BH, Manufacturing Lot/
- Serial #
- NL1FG2500004BH/ CBDDG2500032HM/ C1PMT2500086HM; Omni Legend PET Gantry 21cm - Global Haifa LM:
- UDI
- (01)00195278592309(21)OH4E43005(11)250609, Manufacturing Lot/
- Serial #
- OH4E43005; Omni Legend PET Gantry 21cm - Global Haifa LM:
- UDI
- (01)00195278592309(21)OH4E43003(11)250300, Manufacturing Lot/
- Serial #
- OH4E43003; Omni Legend PET Gantry 21cm - Mobile:
- UDI
- (01)00195278454218(21)OW4D47001(11)241100, Manufacturing Lot/
- Serial #
- OW4D47001; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44003(11)240800, Manufacturing Lot/
- Serial #
- OM4D44003; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44009(11)241100, Manufacturing Lot/
- Serial #
- OM4D44009; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44002(11)240500, Manufacturing Lot/
- Serial #
- OM4D44002; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44006(11)241000, Manufacturing Lot/
- Serial #
- OM4D44006; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4E44017(11)250528, Manufacturing Lot/
- Serial #
- OM4E44017; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44008(11)241100, Manufacturing Lot/
- Serial #
- OM4D44008; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44005(11)241000, Manufacturing Lot/
- Serial #
- OM4D44005; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4E44015(11)250512, Manufacturing Lot/
- Serial #
- OM4E44015; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4E44013(11)250300, Manufacturing Lot/
- Serial #
- OM4E44013; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4E44010(11)250300, Manufacturing Lot/
- Serial #
- OM4E44010; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44007(11)241100, Manufacturing Lot/
- Serial #
- OM4D44007; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4E44016(11)250525, Manufacturing Lot/
- Serial #
- OM4E44016; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44001(11)240300, Manufacturing Lot/
- Serial #
- OM4D44001; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4E44011(11)250200, Manufacturing Lot/
- Serial #
- OM4E44011; Omni Legend PET Gantry 21cm WSO LM:
- UDI
- (01)00195278454218(21)OM4D44004(11)240900, Manufacturing Lot/
- Serial #
- OM4D44004; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)241000(21)NL1DG2400006BH, Manufacturing Lot/
- Serial #
- NL1DG2400006BH /CBDDG2400115HM /C1PMT2400277HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250619(21)NL1DG2500007BH, Manufacturing Lot/
- Serial #
- NL1DG2500007BH/ CBDDG2500042HM/C1PMT2500116HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)240700(21)NL1DG2400003BH, Manufacturing Lot/
- Serial #
- NL1DG2400003BH/ CBDDG2400091HM/ C1PMT2400185HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250521(21)NL1DG2500005BH, Manufacturing Lot/
- Serial #
- NL1DG2500005BH/ CBDDG2500037HM/ C1PMT2500093HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250702(21)NL1DG2500008BH, Manufacturing Lot/
- Serial #
- NL1DG2500008BH/ CBDDG2500043HM/ C1PMT2500121HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250515(21)NL1DG2500004BH, Manufacturing Lot/
- Serial #
- NL1DG2500004BH/ CBDDG2500034HM/ C1PMT2500089HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)240700(21)NL1DG2400002BH, Manufacturing Lot/
- Serial #
- NL1DG2400002BH/ CBDDG2400083HM/ C1PMT2400172HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)240700(21)NL1DG2400004BH, Manufacturing Lot/
- Serial #
- NL1DG2400004BH/ CBDDG2400096HM /C1PMT2400197HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250611(21)NL1DG2500006BH, Manufacturing Lot/
- Serial #
- NL1DG2500006BH/ CBDDG2500040HM/ C1PMT2500111HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)231100(21)NL1DG2400001BH, Manufacturing Lot/
- Serial #
- NL1DG2400001BH; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250200(21)NL1DG2500002BH, Manufacturing Lot/
- Serial #
- NL1DG2500002BH/ CBDDG2500015HM/ C1PMT2500053HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)241100(21)NL1DG2400007BH, Manufacturing Lot/
- Serial #
- NL1DG2400007BH /CBDDG2400131HM/ C1PMT2400328HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)240800(21)NL1DG2400005BH, Manufacturing Lot/
- Serial #
- NL1DG2400005BH/ CBDDG2400108HM /C1PMT2400226; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)241200(21)NL1DG2400008BH, Manufacturing Lot/
- Serial #
- NL1DG2400008BH/ CBDDG2400142HM/ C1PMT2400342HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250400(21)NL1DG2500003BH, Manufacturing Lot/
- Serial #
- NL1DG2500003BH /CBDDG2500025HM/ C1PMT2500071HM; Omni Legend PET Gantry 32cm - MEA:
- UDI
- (01)00195278792822(11)250100(21)NL1DG2500001BH, Manufacturing Lot/
- Serial #
- NL1DG2500001BH/ CBDDG2500007HM/ C1PMT2500012HM; Omni Legend PET Gantry 32cm Haifa LM:
- UDI
- (01)00195278592309(21)OH6D66004(11)241100, Manufacturing Lot/
- Serial #
- OH6D66004; Omni Legend PET Gantry 32cm Haifa LM:
- UDI
- (01)00195278592309(21)OH6D66001(11)240200, Manufacturing Lot/
- Serial #
- OH6D66001; Omni Legend PET Gantry 32cm Haifa LM:
- UDI
- (01)00195278592309(21)OH6D66002(11)240500, Manufacturing Lot/
- Serial #
- OH6D66002; Omni Legend PET Gantry 32cm Haifa LM:
- UDI
- (01)00195278592309(21)OH6D66003(11)241000, Manufacturing Lot/
- Serial #
- OH6D66003; Omni Legend PET Gantry 32cm Mobile:
- UDI
- (01)00195278454218(21)OW6D62001(11)240200, Manufacturing Lot/
- Serial #
- OW6D62001; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31063(11)240100, Manufacturing Lot/
- Serial #
- OM3D31063; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31072(11)240200, Manufacturing Lot/
- Serial #
- OM3D31072; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31064(11)240100, Manufacturing Lot/
- Serial #
- OM3D31064; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31050(11)231100, Manufacturing Lot/
- Serial #
- OM3C31050; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31044(11)231100, Manufacturing Lot/
- Serial #
- OM3C31044; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31058(11)240100, Manufacturing Lot/
- Serial #
- OM3D31058; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31009(11)230200, Manufacturing Lot/
- Serial #
- OM3C31009; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31065(11)240100, Manufacturing Lot/
- Serial #
- OM3D31065; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31040(11)231000, Manufacturing Lot/
- Serial #
- OM3C31040; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31025(11)230600, Manufacturing Lot/
- Serial #
- OM3C31025; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31059(11)240100, Manufacturing Lot/
- Serial #
- OM3D31059; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31069(11)240200, Manufacturing Lot/
- Serial #
- OM3D31069; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31034(11)230800, Manufacturing Lot/
- Serial #
- OM3C31034; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31015(11)230300, Manufacturing Lot/
- Serial #
- OM3C31015; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31021(11)230500, Manufacturing Lot/
- Serial #
- OM3C31021; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31102(11)240700, Manufacturing Lot/
- Serial #
- OM3D31102; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31103(11)240700, Manufacturing Lot/
- Serial #
- OM3D31103; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31061(11)240100, Manufacturing Lot/
- Serial #
- OM3D31061; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31091(11)240500, Manufacturing Lot/
- Serial #
- OM3D31091; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31079(11)240400, Manufacturing Lot/
- Serial #
- OM3D31079; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31006(11)230100, Manufacturing Lot/
- Serial #
- OM3C31006; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31074(11)240200, Manufacturing Lot/
- Serial #
- OM3D31074; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31056(11)240100, Manufacturing Lot/
- Serial #
- OM3D31056; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31042(11)231000, Manufacturing Lot/
- Serial #
- OM3C31042; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31097(11)240600, Manufacturing Lot/
- Serial #
- OM3D31097; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31007(11)230100, Manufacturing Lot/
- Serial #
- OM3C31007; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31053(11)231100, Manufacturing Lot/
- Serial #
- OM3C31053; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31038(11)231000, Manufacturing Lot/
- Serial #
- OM3C31038; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31081(11)240400, Manufacturing Lot/
- Serial #
- OM3D31081; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31062(11)240100, Manufacturing Lot/
- Serial #
- OM3D31062; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31090(11)240500, Manufacturing Lot/
- Serial #
- OM3D31090; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31043(11)231100, Manufacturing Lot/
- Serial #
- OM3C31043; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31075(11)240200, Manufacturing Lot/
- Serial #
- OM3D31075; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31078(11)240400, Manufacturing Lot/
- Serial #
- OM3D31078; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31084(11)240400, Manufacturing Lot/
- Serial #
- OM3D31084; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31028(11)230700, Manufacturing Lot/
- Serial #
- OM3C31028; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31037(11)231000, Manufacturing Lot/
- Serial #
- OM3C31037; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31114(11)241200, Manufacturing Lot/
- Serial #
- OM3D31114; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31104(11)240700, Manufacturing Lot/
- Serial #
- OM3D31104; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31066(11)240100, Manufacturing Lot/
- Serial #
- OM3D31066; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31014(11)230300, Manufacturing Lot/
- Serial #
- OM3C31014; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31027(11)230700, Manufacturing Lot/
- Serial #
- OM3C31027; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3B31004(11)221200, Manufacturing Lot/
- Serial #
- OM3B31004; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31086(11)240400, Manufacturing Lot/
- Serial #
- OM3D31086; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31024(11)230600, Manufacturing Lot/
- Serial #
- OM3C31024; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31080(11)240400, Manufacturing Lot/
- Serial #
- OM3D31080; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31096(11)240600, Manufacturing Lot/
- Serial #
- OM3D31096; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31047(11)231100, Manufacturing Lot/
- Serial #
- OM3C31047; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31035(11)230800, Manufacturing Lot/
- Serial #
- OM3C31035; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31085(11)240400, Manufacturing Lot/
- Serial #
- OM3D31085; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31011(11)230200, Manufacturing Lot/
- Serial #
- OM3C31011; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31008(11)230200, Manufacturing Lot/
- Serial #
- OM3C31008; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31049(11)231100, Manufacturing Lot/
- Serial #
- OM3C31049; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31073(11)240200, Manufacturing Lot/
- Serial #
- OM3D31073; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31093(11)240500, Manufacturing Lot/
- Serial #
- OM3D31093; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31022(11)230500, Manufacturing Lot/
- Serial #
- OM3C31022; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31101(11)240700, Manufacturing Lot/
- Serial #
- OM3D31101; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31033(11)230800, Manufacturing Lot/
- Serial #
- OM3C31033; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31077(11)240400, Manufacturing Lot/
- Serial #
- OM3D31077; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31105(11)240700, Manufacturing Lot/
- Serial #
- OM3D31105; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31010(11)230200, Manufacturing Lot/
- Serial #
- OM3C31010; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31020(11)230500, Manufacturing Lot/
- Serial #
- OM3C31020; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3B31005(11)221200, Manufacturing Lot/
- Serial #
- OM3B31005; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31013(11)230300, Manufacturing Lot/
- Serial #
- OM3C31013; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31076(11)240400, Manufacturing Lot/
- Serial #
- OM3D31076; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31088(11)240500, Manufacturing Lot/
- Serial #
- OM3D31088; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31051(11)231100, Manufacturing Lot/
- Serial #
- OM3C31051; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31095(11)240500, Manufacturing Lot/
- Serial #
- OM3D31095; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31055(11)240100, Manufacturing Lot/
- Serial #
- OM3D31055; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31023(11)230500, Manufacturing Lot/
- Serial #
- OM3C31023; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3B31001(11)220600, Manufacturing Lot/
- Serial #
- OM3B31001; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31029(11)230700, Manufacturing Lot/
- Serial #
- OM3C31029; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31019(11)230500, Manufacturing Lot/
- Serial #
- OM3C31019; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31041(11)231000, Manufacturing Lot/
- Serial #
- OM3C31041; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31016(11)230300, Manufacturing Lot/
- Serial #
- OM3C31016; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31032(11)230800, Manufacturing Lot/
- Serial #
- OM3C31032; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31094(11)240500, Manufacturing Lot/
- Serial #
- OM3D31094; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31089(11)240500, Manufacturing Lot/
- Serial #
- OM3D31089; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31057(11)240100, Manufacturing Lot/
- Serial #
- OM3D31057; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31107(11)240800, Manufacturing Lot/
- Serial #
- OM3D31107; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31036(11)230900, Manufacturing Lot/
- Serial #
- OM3C31036; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31030(11)230700, Manufacturing Lot/
- Serial #
- OM3C31030; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31012(11)230200, Manufacturing Lot/
- Serial #
- OM3C31012; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31083(11)240400, Manufacturing Lot/
- Serial #
- OM3D31083; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31031(11)230800, Manufacturing Lot/
- Serial #
- OM3C31031; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31112(11)241100, Manufacturing Lot/
- Serial #
- OM3D31112; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31110(11)240800, Manufacturing Lot/
- Serial #
- OM3D31110; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3E31116(11)250100, Manufacturing Lot/
- Serial #
- OM3E31116; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31092(11)240500, Manufacturing Lot/
- Serial #
- OM3D31092; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31113(11)241100, Manufacturing Lot/
- Serial #
- OM3D31113; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31052(11)231100, Manufacturing Lot/
- Serial #
- OM3C31052; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3E31117(11)250400, Manufacturing Lot/
- Serial #
- OM3E31117; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3B31003(11)221100, Manufacturing Lot/
- Serial #
- OM3B31003; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31070(11)240200, Manufacturing Lot/
- Serial #
- OM3D31070; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31067(11)240200, Manufacturing Lot/
- Serial #
- OM3D31067; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31046(11)231100, Manufacturing Lot/
- Serial #
- OM3C31046; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31048(11)231100, Manufacturing Lot/
- Serial #
- OM3C31048; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31039(11)231000, Manufacturing Lot/
- Serial #
- OM3C31039; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31099(11)240700, Manufacturing Lot/
- Serial #
- OM3D31099; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31098(11)240600, Manufacturing Lot/
- Serial #
- OM3D31098; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31111(11)240900, Manufacturing Lot/
- Serial #
- OM3D31111; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3E31118(11)250500, Manufacturing Lot/
- Serial #
- OM3E31118; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31109(11)240900, Manufacturing Lot/
- Serial #
- OM3D31109; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31108(11)240800, Manufacturing Lot/
- Serial #
- OM3D31108; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31068(11)240200, Manufacturing Lot/
- Serial #
- OM3D31068; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31106(11)240800, Manufacturing Lot/
- Serial #
- OM3D31106; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31054(11)231200, Manufacturing Lot/
- Serial #
- OM3C31054; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31017(11)230500, Manufacturing Lot/
- Serial #
- OM3C31017; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31018(11)230500, Manufacturing Lot/
- Serial #
- OM3C31018; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3C31026(11)230600, Manufacturing Lot/
- Serial #
- OM3C31026; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31060(11)240100, Manufacturing Lot/
- Serial #
- OM3D31060; OMNI PET Gantry 15cm:
- UDI
- (01)00195278454218(21)OM3D31082(11)240400, Manufacturing Lot/
- Serial #
- OM3D31082; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250708(21)OMW152500014PT, Manufacturing Lot/
- Serial #
- OMW152500014PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)241004(21)OMW152400004PT, Manufacturing Lot/
- Serial #
- OMW152400004PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)241213(21)OMW152400008PT, Manufacturing Lot/
- Serial #
- OMW152400008PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250102(21)OMW152500010PT, Manufacturing Lot/
- Serial #
- OMW152500010PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)241106(21)OMW152400006PT, Manufacturing Lot/
- Serial #
- OMW152400006PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250410(21)OMW152500012PT, Manufacturing Lot/
- Serial #
- OMW152500012PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250423(21)OMW152500013PT, Manufacturing Lot/
- Serial #
- OMW152500013PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250102(21)OMW152500009PT, Manufacturing Lot/
- Serial #
- OMW152500009PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)240926(21)OMW152400003PT, Manufacturing Lot/
- Serial #
- OMW152400003PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250310(21)OMW152500011PT, Manufacturing Lot/
- Serial #
- OMW152500011PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)241028(21)OMW152400005PT, Manufacturing Lot/
- Serial #
- OMW152400005PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250710(21)OMW152500015PT, Manufacturing Lot/
- Serial #
- OMW152500015PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)241114(21)OMW152400007PT, Manufacturing Lot/
- Serial #
- OMW152400007PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)240919(21)OMW152400002PT, Manufacturing Lot/
- Serial #
- OMW152400002PT; Omni PET Gantry 15cm - WSO:
- UDI
- (01)00195278901439(11)250102(21)OMW152500001PT, Manufacturing Lot/
- Serial #
- OMW152500001PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250623(21)OMC152500008PT, Manufacturing Lot/
- Serial #
- OMC152500008PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250520(21)OMC152500006PT, Manufacturing Lot/
- Serial #
- OMC152500006PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250120(21)OMC152500001PT, Manufacturing Lot/
- Serial #
- OMC152500001PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250325(21)OMC152500005PT, Manufacturing Lot/
- Serial #
- OMC152500005PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250128(21)OMC152500002PT, Manufacturing Lot/
- Serial #
- OMC152500002PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241209(21)OMC152400007PT, Manufacturing Lot/
- Serial #
- OMC152400007PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241120(21)OMC152400004PT, Manufacturing Lot/
- Serial #
- OMC152400004PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241211(21)OMC152400008PT, Manufacturing Lot/
- Serial #
- OMC152400008PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241014(21)OMC152400001PT, Manufacturing Lot/
- Serial #
- OMC152400001PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241018(21)OMC152400002PT, Manufacturing Lot/
- Serial #
- OMC152400002PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250228(21)OMC152500003PT, Manufacturing Lot/
- Serial #
- OMC152500003PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250321(21)OMC152500004PT, Manufacturing Lot/
- Serial #
- OMC152500004PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241023(21)OMC152400003PT, Manufacturing Lot/
- Serial #
- OMC152400003PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241125(21)OMC152400005PT, Manufacturing Lot/
- Serial #
- OMC152400005PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)241204(21)OMC152400006PT, Manufacturing Lot/
- Serial #
- OMC152400006PT; OMNI PET Gantry 15cm Cardiac- WSO:
- UDI
- (01)00195278901439(11)250612(21)OMC152500007PT, Manufacturing Lot/
- Serial #
- OMC152500007PT; OMNI PET Gantry 15cm ES - WSO:
- UDI
- (01)00195278901439(11)250408(21)OMD152500004PT, Manufacturing Lot/
- Serial #
- OMD152500004PT; OMNI PET Gantry 15cm ES - WSO:
- UDI
- (01)00195278901439(11)250304(21)OMD152500003PT, Manufacturing Lot/
- Serial #
- OMD152500003PT; OMNI PET Gantry 15cm ES - WSO:
- UDI
- (01)00195278901439(11)250218(21)OMD152500002PT, Manufacturing Lot/
- Serial #
- OMD152500002PT; OMNI PET Gantry 15cm ES - WSO:
- UDI
- (01)00195278901439(11)250603(21)OMD152500006PT, Manufacturing Lot/
- Serial #
- OMD152500006PT; OMNI PET Gantry 15cm ES - WSO:
- UDI
- (01)00195278901439(11)250410(21)OMD152500005PT, Manufacturing Lot/
- Serial #
- OMD152500005PT; OMNI PET Gantry 15cm ES - WSO:
- UDI
- (01)00195278901439(11)250213(21)OMD152500001PT, Manufacturing Lot/
- Serial #
- OMD152500001PT; Omni PET Gantry 15cm Mobile WSO:
- UDI
- (01)00195278901439(11)241217(21)OMM152400001PT, Manufacturing Lot/
- Serial #
- OMM152400001PT; Omni PET Gantry 15cm Mobile WSO:
- UDI
- (01)00195278901439(11)250206(21)OMM152500001PT, Manufacturing Lot/
- Serial #
- OMM152500001PT; Omni PET Gantry 15cm Mobile WSO:
- UDI
- (01)00195278901439(11)250410(21)OMM152500002PT, Manufacturing Lot/
- Serial #
- OMM152500002PT; Omni PET Gantry 21cm - WSO:
- UDI
- (01)00195278901439(11)250617(21)OMW212500007PT, Manufacturing Lot/
- Serial #
- OMW212500007PT; Omni PET Gantry 21cm - WSO:
- UDI
- (01)00195278901439(11)250220(21)OMW212500001PT, Manufacturing Lot/
- Serial #
- OMW212500001PT; Omni PET Gantry 21cm - WSO:
- UDI
- (01)00195278901439(11)250604(21)OMW212500006PT, Manufacturing Lot/
- Serial #
- OMW212500006PT; Omni PET Gantry 21cm - WSO:
- UDI
- (01)00195278901439(11)250519(21)OMW212500004PT, Manufacturing Lot/
- Serial #
- OMW212500004PT; Omni PET Gantry 21cm - WSO:
- UDI
- (01)00195278901439(11)250501(21)OMW212500003PT, Manufacturing Lot/
- Serial #
- OMW212500003PT; Omni PET Gantry 21cm - WSO:
- UDI
- (01)00195278901439(11)250313(21)OMW212500002PT, Manufacturing Lot/
- Serial #
- OMW212500002PT; Omni PET Gantry 21cm - WSO:
- UDI
- (01)00195278901439(11)250529(21)OMW212500005PT, Manufacturing Lot/
- Serial #
- OMW212500005PT; Omni PET Gantry 21cm Mobile - WSO:
- UDI
- (01)00195278901439(11)250710(21)OMM212500001PT, Manufacturing Lot/
- Serial #
- OMM212500001PT; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6C61041(11)230900, Manufacturing Lot/
- Serial #
- OM6C61041; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6C61020(11)230500, Manufacturing Lot/
- Serial #
- OM6C61020; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6B61010(11)221100, Manufacturing Lot/
- Serial #
- OM6B61010; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6D61070(11)240600, Manufacturing Lot/
- Serial #
- OM6D61070; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6C61050(11)231100, Manufacturing Lot/
- Serial #
- OM6C61050; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6C61053(11)231100, Manufacturing Lot/
- Serial #
- OM6C61053; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6D61083(11)240800, Manufacturing Lot/
- Serial #
- OM6D61083; OMNI PET Gantry 30cm:
- UDI
- (01)00195278454218(21)OM6C61021(11)230500, Manufacturing Lot/
- Serial #
- OM6C61021; OMNI PET
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Additional code information
Gantry 30cm: UDI (01)00195278454218(21)OM6C61019(11)230500, Manufacturing Lot/Serial Number OM6C61019; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61065(11)240500, Manufacturing Lot/Serial Number OM6D61065; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61045(11)231000, Manufacturing Lot/Serial Number OM6C61045; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61024(11)230500, Manufacturing Lot/Serial Number OM6C61024; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61066(11)240500, Manufacturing Lot/Serial Number OM6D61066; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61040(11)230800, Manufacturing Lot/Serial Number OM6C61040; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61077(11)240800, Manufacturing Lot/Serial Number OM6D61077; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61028(11)230700, Manufacturing Lot/Serial Number OM6C61028; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61026(11)230600, Manufacturing Lot/Serial Number OM6C61026; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61058(11)240100, Manufacturing Lot/Serial Number OM6D61058; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61022(11)230500, Manufacturing Lot/Serial Number OM6C61022; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61068(11)240500, Manufacturing Lot/Serial Number OM6D61068; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61012(11)230100, Manufacturing Lot/Serial Number OM6B61012; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61037(11)230800, Manufacturing Lot/Serial Number OM6C61037; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61075(11)240700, Manufacturing Lot/Serial Number OM6D61075; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61025(11)230600, Manufacturing Lot/Serial Number OM6C61025; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61032(11)230700, Manufacturing Lot/Serial Number OM6C61032; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61004(11)221000, Manufacturing Lot/Serial Number OM6B61004; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61056(11)231200, Manufacturing Lot/Serial Number OM6C61056; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61059(11)240100, Manufacturing Lot/Serial Number OM6D61059; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61091(11)241000, Manufacturing Lot/Serial Number OM6D61091; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61087(11)240900, Manufacturing Lot/Serial Number OM6D61087; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61048(11)231000, Manufacturing Lot/Serial Number OM6C61048; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61099(11)250200, Manufacturing Lot/Serial Number OM6E61099; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61023(11)230500, Manufacturing Lot/Serial Number OM6C61023; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61036(11)230800, Manufacturing Lot/Serial Number OM6C61036; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61067(11)240500, Manufacturing Lot/Serial Number OM6D61067; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61029(11)230700, Manufacturing Lot/Serial Number OM6C61029; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61057(11)240100, Manufacturing Lot/Serial Number OM6D61057; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61096(11)250100, Manufacturing Lot/Serial Number OM6E61096; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61076(11)240700, Manufacturing Lot/Serial Number OM6D61076; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61030(11)230700, Manufacturing Lot/Serial Number OM6C61030; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61069(11)240600, Manufacturing Lot/Serial Number OM6D61069; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61042(11)230900, Manufacturing Lot/Serial Number OM6C61042; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61035(11)230700, Manufacturing Lot/Serial Number OM6C61035; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61062(11)240300, Manufacturing Lot/Serial Number OM6D61062; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61080(11)240800, Manufacturing Lot/Serial Number OM6D61080; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61054(11)231100, Manufacturing Lot/Serial Number OM6C61054; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61071(11)240600, Manufacturing Lot/Serial Number OM6D61071; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61085(11)240900, Manufacturing Lot/Serial Number OM6D61085; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61078(11)240800, Manufacturing Lot/Serial Number OM6D61078; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61064(11)240400, Manufacturing Lot/Serial Number OM6D61064; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61090(11)241000, Manufacturing Lot/Serial Number OM6D61090; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61033(11)230700, Manufacturing Lot/Serial Number OM6C61033; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61100(11)250400, Manufacturing Lot/Serial Number OM6E61100; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61011(11)221200, Manufacturing Lot/Serial Number OM6B61011; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61095(11)241200, Manufacturing Lot/Serial Number OM6D61095; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61104(11)250612, Manufacturing Lot/Serial Number OM6E61104; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61073(11)240700, Manufacturing Lot/Serial Number OM6D61073; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61081(11)240800, Manufacturing Lot/Serial Number OM6D61081; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61038(11)230800, Manufacturing Lot/Serial Number OM6C61038; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61008(11)221100, Manufacturing Lot/Serial Number OM6B61008; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61039(11)230800, Manufacturing Lot/Serial Number OM6C61039; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61074(11)240700, Manufacturing Lot/Serial Number OM6D61074; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61013(11)230100, Manufacturing Lot/Serial Number OM6C61013; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61014(11)230100, Manufacturing Lot/Serial Number OM6C61014; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61047(11)231000, Manufacturing Lot/Serial Number OM6C61047; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61034(11)230700, Manufacturing Lot/Serial Number OM6C61034; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61015(11)230100, Manufacturing Lot/Serial Number OM6C61015; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61006(11)221000, Manufacturing Lot/Serial Number OM6B61006; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61055(11)231100, Manufacturing Lot/Serial Number OM6C61055; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61061(11)240200, Manufacturing Lot/Serial Number OM6D61061; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61005(11)221000, Manufacturing Lot/Serial Number OM6B61005; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61051(11)231100, Manufacturing Lot/Serial Number OM6C61051; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61043(11)231000, Manufacturing Lot/Serial Number OM6C61043; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61094(11)241100, Manufacturing Lot/Serial Number OM6D61094; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61102(11)250400, Manufacturing Lot/Serial Number OM6E61102; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61079(11)240800, Manufacturing Lot/Serial Number OM6D61079; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61018(11)230400, Manufacturing Lot/Serial Number OM6C61018; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61009(11)221100, Manufacturing Lot/Serial Number OM6B61009; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61093(11)241100, Manufacturing Lot/Serial Number OM6D61093; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61044(11)231000, Manufacturing Lot/Serial Number OM6C61044; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61103(11)250603, Manufacturing Lot/Serial Number OM6E61103; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61001(11)220500, Manufacturing Lot/Serial Number OM6B61001; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61007(11)221100, Manufacturing Lot/Serial Number OM6B61007; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61063(11)240400, Manufacturing Lot/Serial Number OM6D61063; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61098(11)250200, Manufacturing Lot/Serial Number OM6E61098; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61016(11)230300, Manufacturing Lot/Serial Number OM6C61016; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61082(11)240800, Manufacturing Lot/Serial Number OM6D61082; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61086(11)240900, Manufacturing Lot/Serial Number OM6D61086; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61092(11)241000, Manufacturing Lot/Serial Number OM6D61092; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61049(11)231000, Manufacturing Lot/Serial Number OM6C61049; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61002(11)220800, Manufacturing Lot/Serial Number OM6B61002; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61046(11)231000, Manufacturing Lot/Serial Number OM6C61046; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61089(11)241000, Manufacturing Lot/Serial Number OM6D61089; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61088(11)241000, Manufacturing Lot/Serial Number OM6D61088; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61017(11)230300, Manufacturing Lot/Serial Number OM6C61017; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61052(11)231100, Manufacturing Lot/Serial Number OM6C61052; OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61105(11)250520, Manufacturing Lot/Serial Number OM6E61105; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)241017(21)OMW302400002PT, Manufacturing Lot/Serial Number OMW302400002PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250115(21)OMW302500002PT, Manufacturing Lot/Serial Number OMW302500002PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250624(21)OMW302500012PT, Manufacturing Lot/Serial Number OMW302500012PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250502(21)OMW302500011PT, Manufacturing Lot/Serial Number OMW302500011PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250625(21)OMW302500013PT, Manufacturing Lot/Serial Number OMW302500013PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250417(21)OMW302500008PT, Manufacturing Lot/Serial Number OMW302500008PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250425(21)OMW302500010PT, Manufacturing Lot/Serial Number OMW302500010PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250423(21)OMW302500009PT, Manufacturing Lot/Serial Number OMW302500009PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)241202(21)OMW302400004PT, Manufacturing Lot/Serial Number OMW302400004PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250331(21)OMW302500007PT, Manufacturing Lot/Serial Number OMW302500007PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)241104(21)OMW302400003PT, Manufacturing Lot/Serial Number OMW302400003PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250210(21)OMW302500003PT, Manufacturing Lot/Serial Number OMW302500003PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250110(21)OMW302500001PT, Manufacturing Lot/Serial Number OMW302500001PT; Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250323(21)OMW302500006PT, Manufacturing Lot/Serial Number OMW302500006PT; Omni PET Gantry 30cm - WSO: UDI (01)001952 …
What the firm is doing
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/24/2025 via letter sent using traceable means. The notice explained the problem with the device, safety issue, and provided recommendations (instructions) for the safe use of the device until the correction can be made. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1112-2026
- FDA 510(k) clearance · K221932The device's official FDA premarket clearance record
- FDA 510(k) clearance · K241665The device's official FDA premarket clearance record
- FDA device classification · KPSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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